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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 5 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

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified...

Investigator:
Philippe Genereux, MD

by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

EARLY-TAVR | PHASE III

Sponsor:
Edwards Lifesciences LLC

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

Inclusion Criteria:
1. Severe aortic stenosis
2. Patient is asymptomatic
3. 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 of the respective clinical site.

Exclusion Criteria:
1. Patient is symptomatic.
2. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
4. Aortic valve is a unicuspid, bicuspid, or is non-calcified.
5. Severe aortic regurgitation (>3+).
6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.

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Contact:
973-971-4205
research@atlantichealth.org

More info:
ClinicalTrials.gov

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

More info:
ClinicalTrials.gov

More Detail
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