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Medical advancements and improvements in how doctors treat disease are made possible by what we learn through clinical trials. Commonly done in a medical setting such as a hospital, clinical trials are research studies that evaluate the safety and effectiveness of new treatments, whether they are drugs, devices, or preventative and other therapeutic measures that can influence health. Patients who participate in clinical trials have the opportunity to access treatments before they are publically available and also help others by contributing to medical research.  

Atlantic Health System hospitals participate in numerous clinical trials in partnership with other research organizations and pharmaceutical or biotech sponsors. Please browse the listing of clinical trials below to learn more about our open and active studies. Our physicians are committed to finding the latest treatments within a variety of medical areas, with a particular focus on cancer, genetics and congenital disease, movement disorders such as Parkinson’s disease, pediatrics, valve disease, and women’s health. 

Showing 7 Results for Aortic Stenosis

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Aortic Stenosis
Open to Enrollment

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Investigator:
John Brown, MD
Partner 3 | PHASE III

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. 65 years of age or older at time of consent.
2. Symptomatic, severe, calcific aortic stenosis with the following TTE criteria:
◦Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
◦AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
3. Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
4. Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
5. NYHA Functional Class ≥ II
6. Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS <4).
7. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:
1. ≥ 1/4 frailty. (Only 0/4 frail patients may be enrolled in the trial).
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Any one of the following criteria meets the diagnosis for MI:
◦Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
◦Symptoms of ischemia
◦New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB)
◦Development of pathological Q waves in the ECG
◦Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
◦Identification of an intracoronary thrombus by angiography
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
4. Severe aortic regurgitation (>3+)
5. Severe mitral regurgitation (>3+)
6. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion).
7. Any patient with a balloon valvuloplasty (BAV) within 30 days of the valve implant procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
8. Any therapeutic invasive cardiac procedure performed within 30 days of the valve implant procedure. Pre-planned PCI performed within 2 weeks prior to valve procedure or implantation of a permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) is not considered exclusionary criteria.
9. Complex coronary artery disease:
◦Unprotected left main coronary artery
◦Syntax score > 32 (in the absence of prior revascularization)
10. Non-complex, flow limiting coronary artery disease requiring revascularization that cannot be treated at the time of or within 2 weeks prior to the valve procedure.
11. Patients with a planned concomitant surgical or transcatheter ablation for atrial fibrillation.
12. Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL)
13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.
14. Emergency interventional/surgical procedures within 30 days of the valve implant procedure
15. Any planned surgical or peripheral procedure to be performed within the 30 day follow-up from the valve implant procedure
16. Hypertrophic cardiomyopathy with or without obstruction (HOCM)
17. Ventricular dysfunction with LVEF < 45%
18. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
19. History of upper GI bleeding within 90 days of the valve implant procedure
20. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure
21. Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure
22. Renal insufficiency (eGFR < 40 ml/min per the Cock-croft-Gault formula) and/or renal replacement therapy at the time of screening
23. Active bacterial endocarditis within 180 days of the valve implant procedure
24. Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
25. Chronic liver disease (MELD Score ≥ 10 or Child-Pugh Class B or C)
26. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
27. Porcelain aorta
28. Complications with prior cardiac surgery (i.e., mediastinitis, prolonged intubation)
29. Patient refuses blood products
30. Severe chest deformity (i.e., pectus excavatum, mastectomy, iatrogenic radiation exposure)
31. BMI > 50 kg/m2
32. Estimated life expectancy < 24 months
33. Known blood dyscrasia
34. Aortic coarctation
35. Absolute contraindications or allergy to iodinated contrast that cannot be pre-medicated
36. Immobility that would prevent completion of study procedures
37. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.
38. Patient refuses SAVR

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Contact:
973-971-4099
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

The Keystone Heart TriGuard™ device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the...

Investigator:
Robert Kipperman, MD

study is to assess the safety and efficacy of the TriGuard™ embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected transcatheter aortic valve implantation (TAVI).

REFLECT | PHASE II/III

Sponsor:
Keystone Heart Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. The patient is a male or non-pregnant female ≥18 years of age
2. The patient meets indications for transcatheter aortic valve implantation (TAVI)
3. The patient is willing to comply with protocol-specified follow-up evaluations
4. The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:
1. Patients undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
2. Patients undergoing transcatheter aortic valve implantation (TAVI) via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
3. Patients with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve transcatheter aortic valve implantation (TAVI))
4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 14 days prior to index procedure per site standard test.
5. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom Creatine Kinase (CK) and CK-MB have not returned to within normal limits at the time of procedure, or patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain.
6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months
7. Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
8. Patients with severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 12 months.
10. Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
11. Patients with hepatic failure (Child-Pugh class C)
12. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
13. Patients presenting with cardiogenic shock at the time of the index procedure.
14. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access
15. Patients in whom the aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous.
16. Patients with any other condition that would prevent adherence to the TriGuard HDH Instructions for Use.
17. Patients with contraindication to cerebral magnetic resonance imaging (MRI).
18. Patients who have a planned treatment with any other investigational device or procedure during the study period.
19. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the transcatheter aortic valve implantation (TAVI) procedure or within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure.

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Contact:
973-971-7541
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

Medtronic CoreValve US Expanded Use Study

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured...

Investigator:
John Brown, MD

by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of =50% at 30 days associated with surgical aortic valve replacement.

Expanded Use

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

Subjects with symptomatic severe aortic stenosis requiring aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days, and at least one of the following conditions:
•Severe (≥3-4+) mitral valve regurgitation
•Severe (≥3-4+) tricuspid valve regurgitation
•End stage renal disease (ESRD) requiring renal replacement therapy
•Low gradient, low output aortic stenosis
•Failed bioprosthetic surgical aortic valve
•2 or more conditions (listed above)

Criteria

Inclusion Criteria:
•Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
•Subjects must meet all of the criteria under at least one of the sub-groups 2a-c:
a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions:
a. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
b. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
c. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification)
AND
ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF < 50%), AND iii. an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
AND/OR
b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF <50%, absence of contractile reserve, a mean gradient <40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization ii. an initial aortic valve area of ≤0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization AND iii. radiographic evidence of severe aortic valve calcification c. Failed bioprosthetic surgical aortic valve

•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
•The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
•The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Clinical
•Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure.
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure
•Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
•Untreated clinically significant coronary artery disease requiring revascularization.
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
•Need for emergency surgery for any reason.
•Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
•Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
•Active Gastrointestinal (GI) bleeding within the past 3 months.
•Hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, warfarin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
•Ongoing sepsis, including active endocarditis.
•Subject refuses a blood transfusion.
•Life expectancy <12 months due to associated non-cardiac co-morbid conditions.
•Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
•Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
•Currently participating in an investigational drug or another device study.
•Symptomatic carotid or vertebral artery disease.

Anatomical
•Native aortic annulus size <18 mm or >29 mm per the baseline diagnostic imaging.
•Pre-existing prosthetic heart valve in the any position
•Moderate to severe mitral stenosis.
•Mixed aortic valve disease: aortic stenosis and aortic regurgitation with predominant aortic regurgitation, (AR is moderate-severe to severe (≥3-4+))(except for failed surgical bioprothesis)
•Hypertrophic obstructive cardiomyopathy.
•Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation.
•Severe basal septal hypertrophy with an outflow gradient.
•Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) >70° (for femoral and left subclavian/axillary access) and >30° (for right subclavian/axillary access).
•Ascending aorta that exceeds the maximum diameter for any given native aortic annulus size (see table below) Aortic Annulus Diameter Ascending Aorta Diameter 18 mm - 20 mm >34 mm 20 mm - 23 mm >40 mm 23 mm - 27 mm >43 mm 27 mm - 29 mm >43 mm
•Congenital bicuspid or unicuspid valve verified by echocardiography.
•Sinus of valsalva anatomy that would prevent adequate coronary perfusion.
•Degenerated surgical bioprothesis presents with a significant concomitant perivalvular leak (between prothesis and native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g. wireform frame fracture) (ONLY FOR TAV in SAV subjects)
•Degenerated surgical bioprothesis presents with a partially detached leaflet that in the aortic position may obstruct a coronary ostium (ONLY FOR TAV in SAV subjects)

Vascular
•Transarterial access not able to accommodate an 18Fr sheath.

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Contact:
973-971-5951
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

SALUS Trial TranScatheter Aortic Valve RepLacement System Pivotal Trial The Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System

Prospective, randomized, unblended, multi-center investigational study with enrollment at up to 45 Investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a comparator...

Investigator:
Robert Kipperman, MD

(Medtronic CoreValve commercially available) in high and extreme risk subjects with severe symptomatic aortic stenosis.

SALUS

Sponsor:
Direct Flow Medical, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. The subject has severe senile degenerative aortic valve stenosis etermined by resting or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s and an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.
2. The subject has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥II)
3. Subject has a documented aortic annulus size of ≥19 mm and <29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient Review Committee [PRC]) and is deemed treatable with an available size of both test and control device..
4. There is agreement by the heart team (which must include a site cardiac interventionalist and two cardiac surgeons that are staff members at the hospital where the procedure is to be performed) that subject is at high operative risk or greater of serious morbidity or mortality with surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and PRC confirmation) and that TAVR is appropriate. Subjects are judged by a heart team, including two cardiac surgeons, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score >8% or at a > 15% risk of mortality at 30 days).This conclusion shall be based on consensus of one cardiac interventionalist and two cardiac surgeons that have examined the subject face to face after careful consideration of the Subject's STS risk score and co-morbidities. NOTE: In the United States, the Centers for Medicare and Medicaid Services (CMS) require independent evaluations by 2 cardiac surgeons for reimbursement.
5. Subject understands the study requirements and the treatment procedures, and provides written informed consent.
6. Subject agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

Exclusion Criteria:
1. Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram.
2. Subjects with an acute STEMI within 30 days preceding the index procedure.
3. Chronic kidney disease (creatinine >3.0 mg/dl, renal replacement therapy at the time of screening or unstable renal function).
4. Subjects with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within 7 days prior to index procedure.
5. Subject has a known contraindication or hypersensitivity to all antithrombin regimens (aspirin, all P2Y12 inhibitors), or inability to be anti-coagulated for the study procedure. Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel.
6. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure unless the BAV is a bridge to the procedure. The bridge BAV must be performed > 72 hours prior to the index procedure.
7. Subjects who are on a waiting list for any organ transplant.
8. Subjects with known other medical illness associated with a life expectancy of less than one year, or expectation that subject will not improve despite treatment of aortic stenosis.
9. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, or polyurethanes
10. Subjects with a history of a stroke or transient ischemic attack TIA) within the prior 6 months of procedure or screening.
11. Subjects with an active gastrointestinal (GI) bleeding (endoscopy proven or bleeding precluding Dual antiplatelet therapy) within the prior 3 months.
12. Subjects presenting with hemodynamic instability or cardiogenic shock requiring inotropic support or mechanical support devices.
13. Subjects who have a planned treatment with any other investigational device or procedure through 1 year follow-up, or who are currently participating in an investigational drug or another device trial.
14. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TAVR procedure.
15. Untreated clinically significant coronary artery disease requiring revascularization.
16. Trans-esophageal echocardiography (TEE) is contraindicated.
17. Active endocarditis or sepsis within 6 months prior to the study procedure.
18. Any condition resulting in inability to provide informed consent for the trial or difficulty in assessment of neurologic status.Anatomic and Vascular Exclusions
19. Congenital bicuspid or unicuspid valve (except as outlined in the planned nested registry).
20. Prior aortic valve surgery or pre-existing prosthetic heart valve in the mitral or aortic position (mitral and tricuspid rings are permissible).
21. A native valve annulus diameter <19mm or ≥29mm determined by the screening CT scan.
22. Echocardiographic evidence of new intra-cardiac mass untreated thrombus, or vegetation that requires treatment.
23. >3+: aortic regurgitation, mitral regurgitation or tricuspid regurgitation.
24. Severe mitral stenosis.
25. Thoracic aortic aneurysm (TAA) >5.50 cm.

Contact:
973-971-5951
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Aortic Stenosis
Open to Enrollment

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve...

Investigator:
John Brown, MD

Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

SURTAVI

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Subject must have STS mortality risk score ≥4% and ≤10%;
•Heart Team (consisting of at least one interventional cardiologist and one cardiac surgeon) unanimously agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
•Subject has severe aortic valve stenosis presenting with
a. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
b. Mean gradient > 40 mmHG or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LEVF) < 55%] or velocity ratio < 0.25;

•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
•Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
•Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:
•Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;
•Any condition considered a contraindication for placement of a bioprosthetic valve (i.e. subject requires a mechanical valve);
•A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
•Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
•Ongoing sepsis, including active endocarditis;
•Any condition considered a contraindication to extracorporeal assistance;
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization;
•Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization;
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
•Recent (within 6 months of randomization)cerebrovascular accident (CVA) or transient ischemic attack (TIA);
•Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
•Subject refuses a blood transfusion;
•Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
•Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
•Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
•Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams;
•Currently participating in an investigational drug or another device trial (excluding registries);
•Evidence of an acute myocardial infarction ≤30 days before the index procedure;
•Need for emergency surgery for any reason;
•True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
•Extensive mediastinal radiation;
•Liver failure (Child-C);
•Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
•Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
•Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
•End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
•Pulmonary Hypertension (systolic pressure> 80mmHg);
•Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
•Frailty assessments identify:
a. Subject is < 80 years of age and three or more of the following apply
b. Subject is ≥ 80 years of age and two or more of the following apply
◾Wheelchair bound
◾Resides in an institutional care facility (e.g. nursing home, skilled care center)
◾Body Mass Index < 20 kg/m2
◾Grip Strength < 16 kg
◾Katz Index Score ≤ 4
◾Albumin < 3.5 g/dL
•Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention;

Note: Additional anatomical and vascular exclusion criteria may apply.

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973-971-5951
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

The Medtronic TAVR 2.0 US Clinical Study

The study objective is to evaluate safety and efficacy of the Medtronic TAVR 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement.

Investigator:
Robert Kipperman, MD
TAVR 2.0

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: Child, Adult, Senior
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
2. STS score of ≥8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities
3. Symptoms of aortic stenosis AND NYHA Functional Class II or greater
4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:
1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
2. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
◦aspirin or heparin (HIT/HITTS) and bivalirudin
◦ticlopidine and clopidogrel
◦nitinol (titanium or nickel)
◦contrast media
3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
4. Untreated clinically significant coronary artery disease requiring revascularization
5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
6. End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
7. Ongoing sepsis, including active endocarditis
8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
13. Subject refuses a blood transfusion
14. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
16. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
17. Currently participating in an investigational drug or another device study (excluding registries)
18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
19. Need for emergency surgery for any reason
20. Liver failure (Child-Pugh class C)
21. Subject is pregnant or breast feeding
22. Pre existing prosthetic heart valve in any position
23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
24. Severe mitral regurgitation
25. Severe tricuspid regurgitation
26. Moderate or severe mitral stenosis
27. Hypertrophic obstructive cardiomyopathy
28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
29. Congenital bicuspid or unicuspid valve verified by echocardiography
30. Access vessel diameter <5.5 mm or <6.0 mm for patent LIMA

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Contact:
973-971-5951
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Aortic Stenosis
Open to Enrollment

Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high...

Investigator:
Barry Cohen, MD

risk for surgical valve replacement.

REPRISE III

Sponsor:
Boston Scientific Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subject has documented calcific, severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure gradient ≥40 mm Hg or jet velocity ≥4.0 m/s, as measured by echocardiography and/or invasive hemodynamics
2. Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and is deemed treatable with an available size of both test and control device
3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II
4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.
◦Society of Thoracic Surgeons (STS) score ≥8% -OR-
◦If STS <8, subject has at least one of the following conditions: Age ≥ 90, hostile chest, porcelain aorta, severe pulmonary hypertension (>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second [FEV1] <50% of predicted, diffusing capacity of the lungs for carbon monoxide [DLCO] <60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5‑meter walk >6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index <21, wheelchair bound, unable to live independently, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)
5. Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
6. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
7. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).

Exclusion Criteria:
1. Subject has a congenital unicuspid or bicuspid aortic valve.
2. Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
4. Subject has end-stage renal disease or has glomerular filtration rate (GFR) <20 (based on Cockcroft-Gault formula).
5. Subject has a pre-existing prosthetic aortic or mitral valve.
6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
7. Subject has a need for emergency surgery for any reason.
8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
9. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
10. Subject has (hemoglobin) Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
12. Subject has active peptic ulcer disease or gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
15. Subject has hypertrophic obstructive cardiomyopathy.
16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker implantation, which are allowed).
17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
20. Subject has severe peripheral vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely), marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid or vertebral disease.
21. Subject has thick (>5 mm) protruding or ulcerated atheroma in the aortic arch
22. Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use.
23. Subject has current problems with substance abuse (e.g., alcohol, etc.).
24. Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
25. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
26. Subject has severe incapacitating dementia.