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Introduction
Clinical trials are carefully designed investigations to determine the natural course of a cardiac condition, and often to test the value (safety and benefit) of a treatment modality. Clinical trials are necessary preludes to the widespread introduction of new treatment. Clinical trials are often designed so that a standard treatment is compared to a newer treatment, and some are designed to test a new treatment in comparison to placebo.
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To Enroll in a Trial
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Do you want to participate in a clinical trial?
Please contact Robin Knox, RN at rknox@chpnet.org.
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Clinical trials are frequently sponsored by the National Institute of Health, but other scientific organizations or industrial entities may sponsor and support these trials. Clinical trials may make available newer or innovative treatments not approved for general usage.
As a leading academic institution, and component of Columbia University, The Arrhythmia Service of St. Luke's-Roosevelt Hospital Center is a leader in the design, conduct, and interpretation of clinical trials for the care of the arrhythmia patient. Below you will find a listing of our currently active clinical trial programs.
ARVD: Multidisciplinary Study of Right Ventricular Dysplasia
Principal Investigator:
Jonathan Steinberg, M.D., FACC
Sponsor:
National Institutes of Heart Lung and Blood (NIHLB)
Contact:
Robin Knox, RN, BA; Amy Malinay, RN; or Jonathan Steinberg, MD - (212) 523-4007
Design:
This five year research plan is a multidisciplinary, multicenter, collaborative study to investigate the cardiac, clinical, and genetic aspects of arrhythmogenic right ventricular dsyplasia.
Target number of patients: 100 probands and 400 related family members
Study duration: 5 years
ICE_PAF
Principal Investigator:
Jonathan Steinberg, MD
Sponsor:
CryoCor Inc.
Contact:
Robin Knox, RN, Amy Malinay, RN or Jonathan Steinberg, MD - (212) 523-4007
Design:
A clinical study to evaluate the safety and efficacy of the CryoCor Cardiac Cryoablation System for the treatment of Paroxysmal Atrial Fibrillation.
Target Number of Patients: 160
Duration: 2 years
MADIT-CRT
Principal Investigator:
Aysha Arshad, MD
Sponsor:
Guidant
Contact:
Ammy Malinay, Robin Knox or Jonathan Steinberg, MD 212-523-4007
Design:
To determine if Cardiac resynchronization therapy with an Implantable Cardioverter Defibrillator (CRT-D) can improve or reduce progressive heart failure in people with high risk cardiac disease with advanced left ventricular dysfunction. Patients will be randomized to defibrillator alone or a defibrillator with CRT.
Target Number of Patients: 1820
Duration: 2 years
REVERT
Principal Investigator:
Jonathan Steinberg, MD
Sponsor:
Medtronic, Inc.
Contact:
Robin Knox, RN, Ammy Malinay, RN or Jonathan Steinberg, MD- (212) 523-4007
Design:
Subjects requiring Biventricular pacemaker also known as Cardiac resynchronization therapy (CRT) will be randomized to either conventional placement of the Left ventricular lead or Robotic placement of the left ventricular lead. This study is comparing the best position for optimizing CRT.
Target Number of Patients: 30
Duration: 1 year
ENABLE Study
Endoscopic Ablation System (CF-EAS) for the Treatment of Symptomatic
Atrial Fibrillation.
Principal Investigator:
Jonathan Steinberg, MD
Sponsor:
CardioFocus, Inc.
Contact:
Ammy Malinay, Robin Knox, or Jonathan Steinberg 212-523-4007
Design:
Subjects that are experiencing atrial fibrillation will be randomized to either medications ( control group) or ablation for atrial fibrillation using laser light energy.
Target Number of Patients: 180
Duration: approximately 12 months
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