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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 4 Results for atrial fibrillation

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Atrial Fibrillation
Open to Enrollment


This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary...

Timothy Mahoney, MD

vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.


SentreHEART, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Documented diagnosis of symptomatic persistent or longstanding persistent non-valvular atrial fibrillation
• Failed at least one Class I or III Antiarrythmic drug (AAD)
• Life expectancy ≥ 1 year;
• Willing and able to return to and comply with scheduled follow-up visits and tests; and
• Willing and able to provide written informed consent

Exclusion Criteria:
• Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
• Prior epicardial or endocardial atrial fibrillation ablation procedure;
• LA diameter > 6 cm as measured by computerized tomography;
• Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned intervention;
• Currently exhibits New York Heart Association Class IV heart failure symptoms;
• Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
• Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
• Documented history of unstable angina within 3 months prior to the planned study intervention;
• Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
• End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
• Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
• Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer;
• Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
• Active pericarditis;
• Active endocarditis;
• Any documented history or autoimmune disease associated with pericarditis;
• Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
• Untreated severe scoliosis (documented and clinically defined by treating physician);
• Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
• Documented presence of implanted congenital defect closure devices, (e.g., atrial septal defect, patent foramen ovale or ventricular septal defect device);
• Previously attempted occlusion of the left atrial appendage (by any surgical or percutaneous method);
• Body Mass Index (BMI) > 40;
• Evidence of active Graves disease;

Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging
Subjects will also be excluded if they meet any of the following:
• Based on screening computed tomography angiography performed within 90 days prior to study intervention as confirmed by the core lab:
◦Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e. superior C shape), that has:
a.Left atrial appendage LARIAT-approach width ≥ 40 mm; or
b.Left atrial appendage distal apex extending posterior to the ostium of the appendage.
◦Left atrial appendage positioned behind the pulmonary artery; or
◦All other left atrial morphology: Left atrial appendage LARIAT approach width > 45 mm.
• Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:
◦Intracardiac thrombus; or
◦Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)



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Atrial Fibrillation
Open to Enrollment

reMARQable: nMARQ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Jonathan Sussman, MD

Biosense Webster, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.
3. Age 18 years or older.
4. Signed Patient Informed Consent Form (ICF).
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
2. Previous ablation for atrial fibrillation.
3. Patients on amiodarone at any time during the past 3 months prior to enrollment.
4. AF episodes lasting > 7 days.
5. Any cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
6. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
7. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
8. Documented left atrial thrombus on imaging.
9. History of a documented thromboembolic event within the past one (1) year.
10. Diagnosed atrial myxoma.
11. Presence of implanted cardioverter defibrillator (ICD).
12. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
13. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
14. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
15. Acute illness or active systemic infection or sepsis.
16. Unstable angina.
17. Myocardial infarction within the previous 60 days (2 months).
18. Left ventricular ejection fraction <40%.
19. History of blood clotting or bleeding abnormalities.
20. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
21. Life expectancy less than 365 days (12 months).
22. Enrollment in an investigational study evaluating another device or drug.
23. Uncontrolled heart failure or NYHA Class III or IV heart failure.
24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
25. Presence of a condition that precludes vascular access.
26. Left atrial size >50 mm.



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Open to Enrollment

Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe...

Robert Felberg, MD

blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).


Boehringer Ingelheim Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 150 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion criteria:
• Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset.
• The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke.
• Arterial imaging or cervical plus TCD ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia.
• As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes).

Exclusion criteria:
• Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications.
• Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent AF, c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis.
• Any indication that requires treatment with an anticoagulant as per Investigator`s judgment.
• History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved).
• Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse).
• Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study.



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Open to Enrollment

Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care...

Robert Felberg, MD

(SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Stroke AF | PHASE IV

Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days
• Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up
• Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:
◦ Congestive heart failure
◦ Hypertension (Systolic Blood Pressure > 140)
◦ Diabetes Mellitus
◦ Prior Stroke (>90 days ago, other than study qualifying index event)
◦ Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)

Exclusion Criteria:
• Subject has had a cryptogenic stroke
• Subject has had a cardioembolic stroke
• Subject has untreated hyperthyroidism
• Subject has had a recent myocardial infarction <1 month of stroke
• Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke
• Subject has a mechanical heart valve
• Subject has valvular disease requiring immediate surgical intervention
• Subject has documented prior history of atrial fibrillation or atrial flutter
• Subject has permanent indication for oral anticoagulation
• Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment
• Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.
• Subject's life expectancy is less than 1 year
• Subject is pregnant
• Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor
• Subject with a medical condition that precludes the patient from participation in the opinion of the investigator



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