The Division of Cardiac Services is actively involved in national and international clinical research studies to prove the effectiveness of new treatments for heart disease. A medical center’s participation in such research trials is a good indication of the reputation of its medical staff and the quality of the care they provide.

The dedicated physicians who lead this research at Hackensack University Medical Center are instrumental in the development of new medical advances and treatment protocols. Patients who participate in clinical trials receive excellent care, and they have the satisfaction of knowing that they are helping not just themselves, but future generations as well.

Current research studies include: EARLY DETECTION OF CORNARY ARTERY DISEASE

Beyond Endorsed Lipid Lowering with EBT™ Scanning (BELLES)
Purpose: The purpose of the BELLES study is to measure the effect of 12 months of lipid-lowering medication on a participant’s total coronary calcium score, which is the measurement taken during Electron Beam Tomography (EBT™) scanning to detect Coronary Artery Disease.
Description: All study participants will receive, at no charge, 12 months of FDA-approved cholesterol-lowering medication, periodic checkups and two EBT™ scans.
Eligibility: To be eligible for the BELLES study, you must be a woman who is:
1. 55 to 75 years of age
2. postmenopausal (no menstrual period for at least one year or on hormone replacement therapy for one year)
3. diagnosed with high cholesterol and not taking any cholesterol-lowering drugs for the past 3 months.
Recruitment Status: This study has reached capacity and is closed to new participants.
Principal Investigator: Louis Evan Teichholz, MD
Contact Information: Kathleen Dowd, RN, Research Coordinator, 201-996-3990.
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TREATMENT OF HEART FAILURE
The following three clinical trials are open to certain patients diagnosed with heart failure:

Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION)
Purpose: The purpose of the COMPANION study for heart failure patients is to reduce all-cause mortality, cardiac morbidity, and hospitalization; increase long-term survival; and increase the functional capacity of participants.
Description: Participants will receive one of three types of treatments for heart failure. The study will compare the long-term effectiveness of these three types of treatments: optimal drug therapy; drug therapy and electrical stimulation that synchronizes the heart (a pacemaker); or the combination of drug therapy, electrical stimulation and an implantable cardiovascular defibrillator (ICD).
Eligibility: Participants must have symptomatic heart failure, left ventricular dysfunction, a wide QRS complex and no conventional device indication.
Recruitment Status: This study is open to enrollment and participants are still being accepted.
Principal Investigator: Robert Berkowitz, MD
Contact Information: Donna Hesari, RN, Research Coordinator, (201) 996-2000, ext, 61813.

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Multicenter, InSync™ Randomized Clinical Evaluation (MIRACLE) ICD Study
Purpose: The purpose of the MIRACLE study is to evaluate the safety and effectiveness of the InSync™ Implantable Cardioverter Defibrillator (ICD) device. The InSync™ ICD system is designed to treat abnormally fast heart rhythms and improve the symptoms of chronic heart failure by resynchronizing the left and right ventricles.
Description: Patients in this study will have the InSync™ ICD system implanted. The system provides two benefits for patients: special leads continuously monitor the heart and the unit provides immediate electrical pacing and/or defibrillator therapies when needed. This not only improves the symptoms of chronic heart failure, it also protects patients from abnormal heart rhythms that could cause sudden cardiac death.
Eligibility: Patients who qualify for the study must have chronic heart failure, combined with either an intraventricular conduction (IVC) defect or bundle block branch (BBB), either of which would place them at an increased risk for sudden cardiac death.
Recruitment Status: This study has reached capacity and is closed to new participants.
Prinicpal Investigator: John Zimmerman, MD
Contact Information: Tisha Arakelian, RN, Clinical Research Nurse, (201) 996-2624.

Treatment of Heart Block/Chronic Atrial Fibrillation

Post AV Node Ablation Evaluation (PAVE) Study
Purpose: The purpose of the PAVE study is to evaluate the benefits of right, left, or biventricular pacing with the Aescula™ left heart lead delivery system, along with the Affinity™ or Frontier™ pacemakers.
Description: The goal of this study is to compare the effects of three different modes of pacing on the patients’ functional status and quality of life. The study will evaluate the electrical and safety performance of the Aescula™ leads as well as safety performance of the entire implanted pacing system. Patients randomized to the left or bi-ventricular arm of this study will receive the left heart pacing delivery system designed by St. Jude Medical.
Eligibility: Patients chosen for this study are those who require AV node ablation resulting in third degree heart block, followed by permanent pacemaker implant due to chronic atrial fibrillation.
Recruitment Status: This study is open to enrollment and participants are still being accepted.
Prinicpal Investigator: John Zimmerman, M.D.
Contact Information: Tisha Arakelian, RN, Clinical Research Nurse, (201) 996-2624.

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