The Cardiac Research program at Newark Beth Israel and Saint Barnabas
Medical Centers performs clinical research trials and program-initiated
research projects in a variety of subspecialties of Cardiac Services,
including diagnostic, invasive and non-invasive Cardiology, Electrophysiology,
Heart Failure management as well as Cardiothoracic Surgery and Cardiac
Transplantation. In 2005, the Cardiac Research team worked on 28 research
studies and enrolled over 120 patients.
Lead by our experienced medical staff, the Cardiac Research team includes
dedicated clinical research coordinators, a research assistant and an
administrative director.
ArgiNOx Pharmaceuticals, Inc.
David
Baran, MD, FACC
TRIUMPH is a phase III international study to evaluate a first-in-class
drug to treat cardiogenic shock (CS) following acute myocardial infarction.
Despite major advances in acute cardiac care over the past two decades,
the death rate of CS remains 40-50% or higher. TRIUMPH will evaluate
the efficacy of Tilarginine Acetate to improve survival of these patients.
The primary endpoint of the study is mortality at 30 days.
Newark Beth Israel Medical Center also participated
in, and was the top enroller worldwide for, the phase II trial of the
same compound (SHOCK 2).
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CarboMedics, Inc.
Craig R. Saunders, MD
©2005 CarboMedics Inc.
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Newark Beth Israel is one of the lead centers
conducting the non-randomized trial of the Mitroflow Aortic Pericardial
Heart Valve. The Mitroflow valve has been commercially available outside
the United States for the past 22 years. Since the safety and effectiveness
of the Mitroflow valve has not been proven in the United States, the
goal of this study is to obtain data to support a pre-marketing application
(PMA) to the U.S. Food and Drug Administration (FDA) to commercially
sell the Mitroflow valve in the United States. The Mitroflow valve is
constructed from a single piece of bovine pericardium wrapped around
a supporting stent. |
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Aventis,
Inc.
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Marc Cohen, MD, FACC
The trial is intended to determine the effect of several IV regimens of otamixaban
on pharmacodynamic markers – including markers of thrombosis and coagulation – safety/
tolerability, clinical efficacy and pharmacokinetics in patients undergoing
non-urgent angioplasty procedures via a femoral approach. 930 patients are
to be enrolled over 80-100 sites in 10 countries, including Belgium, Canada,
Czech Republic, France, Germany, Netherlands, Slovakia, South Africa, Spain
and the United States.
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Medtronic, Inc.
Mark
Zucker, MD, JD, FACC, FACP, and Marc Roelke,
MD, FACC
The Chronicle device is an implantable hemodynamic monitor approximately the
size of an average pacemaker. The nation-wide COMPASS-HF study was performed
to assess the safety and effectiveness of continuous ambulatory cardiac pressures
in hopes of improving heart failure morbidity. The COMPASS-HF study is no longer
enrolling subjects but is following study subjects long-term.
Notice of Availability: Investigational
Device.
Limited by US Law to Investigational Use
 Implantable
Hemodynamic Monitor
• Pressure sensor is implanted in RVOT
• Implanting technique similar to pacemaker
External Pressure Reference
• Pager sized external device which measures barometric pressure
• Is designed to correct absolute cardiac pressure, recorded in hemodynamic
monitor, for changes in atmospheric pressure
Remote Monitor
• Home unit which allows patients to send Chronicle® data to a secure
network
Chronicle® Information Network
• Web site which allows clinicians to view and evaluate Chronicle® data
over time
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Medtronic, Inc.
Marc Roelke, MD, FACC
This investigator-initiated randomized single-blinded study aims to begin
development of an optimal long-term clinical-management model for the ICD patient
population. The primary goal is to test the integrative medicine (IM) approach
to care of ICD patients against the currently accepted traditional medical
model. The researchers hope to demonstrate that the IM approach to treatment
of ICD patients – including the best of traditional medical care, inpatient
CAM therapies and the outpatient Mindfulness-Based Stress Reduction and Relaxation
program (created by J. Kabat-Zinn, PhD) – will have a relative positive
impact on overall psychological and physiological well-being of ICD recipients.
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Acorn Cardiovascular,
Inc.
Margarita
Camacho, MD
The Acorn Clinical Trial is the most extensive pre-market evaluation of a
surgical treatment for heart failure ever undertaken, involving 300 patients
at 29 centers across North America, including Newark Beth Israel. This trial
was conducted to evaluate effectiveness of CorCap CSD therapy in the treatment
of heart failure patients with an enlarged heart and progressive symptoms despite
optimized drug therapy.
The CorCap™ Cardiac Support Device (CSD), a proprietary mesh wrap that
is implanted around the heart, was developed to provide gentle support to the
heart, while allowing normal cardiac function. The CorCap CSD is intended to
prevent and reverse the progression of heart failure by improving the heart’s
structure and function, leading to improvements in the quality of a patient’s
life.
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St. Jude Medical
Roy Sauberman, MD, FACC
Atrial fibrillation (AF) is frequently associated with bradycardia (sick sinus
syndrome) and increased vagal tone, and symptoms associated with AF include
stroke, heart failure and incapacitating palpitations. Overdrive pacing minimizes
pauses following ectopic beats, reduces the dispersion of refractoriness, and
suppresses ectopic foci, which may be effective in preventing recurrent AF.
St. Jude Medical has recently developed a unique overdrive suppression algorithm,
AF Suppression, which supports circadian rhythm variation while delivering
a high percentage of atrial pacing. The purpose of the ASSIST study is to evaluate
the clinical benefits and outcomes of AF Suppression pacing in patients with
an implantable cardioverter-defibrillator (ICD) indication. These benefits
may include a reduction in atrial arrhythmia incidence and atrial arrhythmia
burden as well as a reduction of inappropriate VT/VF device therapy.
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