CLINICAL TRIALS
SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial
Principal Investigators: Jonathan Steinberg, MD, FACC
Sponsor: NIH, Medtronic, Wyeth-Ayerst Pharmaceuticals
Contact: Edith Menchavez, RN, MA - (212) 523-4007
Design: This is a double-blind, controlled, multicenter, randomized, primary prevention trial to identify therapy that will significantly reduce death rates in patients with CHF, functional class II-III, resulting from ischemic or non-ischemic cardiomyopathy and LV dysfunction (EF <35%). Patients will be randomized to three (3) treatment groups: automatic implantable cardiac defibrillator (ICD), amiodarone, or placebo. Target number of subjects: 2,500 patients. Study duration: 5 years.
MADIT II: Multicenter Automatic Defibrillator Implantation Trial II
Principal Investigator: Jonathan Steinberg, MD, FACC
Sponsor: Guidant/CPI, Inc.
Contact: Ammy Alburo, RN - (212) 523-4007
Design: This is a multicenter, randomized, primary prevention trial to determine if ischemic cardiomyopathy patients with LV dysfunction (EF <30%) will have improved survival with implantation of an ICD when compared to patients not treated with an ICD. Target number of subjects: 1,500 patients. Study duration: 3-5 years.
MOST: Mode Selection Trial in Sinus Node Dysfunction Trial
Principal Investigator: Frederick Ehlert, MD
Sponsor: NIH
Contact: Edith Menchavez, RN, MA - (212) 523-4007
Design: This is a multicenter, randomized trial to determine if dual chamber pacing (DDDR) is better than single chamber ventricular pacing (VVIR) in patients with sick sinus syndrome. Target number of subjects: 2,500 patients. Study duration: 4-5 years (ending this year).
INSYNC Clinical Study
Principal Investigator: Jonathan Steinberg, MD, FACC); Jonathan Sackner-Bernstein, MD
Sponsor: Medtronic
Contact: Ammy Alburo, RN; Dr. Sackner-Bernstein - (212) 523-4007
Design: This is a multicenter trial to determine the efficacy and safety of Medtronic Insync biventricular pacing system in patients with congestive heart failure, functional class III-IV, with left bundle branch block. This study will examine whether stimulating both ventricles simultaneously (resynchronization) may improve the overall cardiac function and symptoms of heart failure. Target number of subjects: 225 patients. Study Duration: 2-3 years.
AFFIRM: Atrial Fibrillation Follow-up Investigation of Rhythm Management
Principal Investigator: Jonathan Steinberg, MD, FACC
Sponsor: NIH
Contact: Ammy Alburo, RN - (212) 523-4007
Design: This is a multicenter, randomized trial to compare the effect on survival of two treatment strategies , rate control versus rhythm control, commonly employed in patients with atrial fibrillation. Target number of subjects: 5,300 patients. Study duration: 5 years (ending this year).
SPORTIF V: Efficacy and Safety of the Oral Direct Thrombin Inhibitor H376/98 Compared with Dose-Adjusted Warfarin (Coumadin) in the Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation
Principal Investigator: Jonathan Steinberg, MD, FACC; Bengt Herweg, MD
Sponsor: Astra-Zeneca
Contact: Edith Menchavez, RN, MA; Dr. Herweg - (212) 523-4007
Design: This is a multicenter, randomized trial to compare the safety and efficacy of H376/95 (an investigational oral direct thrombin inhibitor) versus dose-adjusted warfarin (Coumadin) for the prevention of all strokes and systemic embolic events in patients with chronic non-valvular atrial fibrillation. Target number of patients: 3,000 patients. Study duration: 2-3 years.
DRI3151: Placebo-Controlled Dose-Finding Safety and Tolerability Study of Dronedarone in Patients with an Implantable Cardioverter Defibrillator (ICD)
Principal Investigator: Jonathan Steinberg, MD, FACC; Margot Vloka, MD, FACC
Sponsor: Sanofi Pharmaceuticals Inc.
Contact: Edith Menchavez, RN, MA; Dr. Vloka - (212) 523-4007
Design: This is a multicenter, randomized, blinded clinical trial to evaluate the safety and tolerability of three different doses of dronedarone (an investigational class III antiarrhythmic drug to control rapid heart rhythm) versus placebo for 1 month in patients with an implantable cardioverter defibrillator who need antiarrhythmic therapy. Target number of subjects: 80 patients. Study duration: 1 year.
Feasibility Evaluation of the Efficacy of Navistar Thermo-Cool Catheter with the Stockert 70 Generator for Endocardial Ablation in Patients with Typical Atrial Flutter
Principal Investigator: Jonathan Steinberg, MD, FACC
Sponsor: Biosense Webster
Contact: Edith Menchavez, RN, MA; Dr. Steinberg - (212) 523-4007
Design: This is a multicenter clinical trial to evaluate the safety and efficacy of an investigational radiofrequency ablation catheter, generator, and mapping system to locate and burn a small region of the heart muscle containing the rapid electrical circuit that is causing the rapid heart rhythm called atrial flutter using an advanced irrigated-tipped catheter. Target number of subjects: 30 patients in the feasibility study then 150 patients in the full scale study. Study duration: 6 mos. to 1 year.
COMPANION: Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure
Principal Investigator: JonathanSteinberg, MD, FACC (EP); Jonathan Sackner-Bernstein, MD, FACC (CHF)
Sponsor: Guidant CPI
Contact: Edith Menchavez, RN, MA; Dr. Steinberg - (212) 523-4007
Design: This is a multicenter, randomized clinical trial to test the potential value of several different treatments ( standard medical therapy vs. biventricular pacemaker + standard medical therapy vs. biventricular pacemaker ICD+ standard medical therapy) for patients with heart failure. Most patients who receive a standard pacemaker or cardioverter defibrillator usually have the leads (wires) placed at the right side of the heart. To receive biventricular pacing therapy, however, an additional lead at the left side of the heart will be placed to pace both sides of the heart simultaneously (resynchronization). Target number of subjects: 2,200 patients. Study duration: 3-4 years.
DAVID: Dual Chamber and VVI Implantable Defibrillator (ICD)Trial
Principal Investigator: Jonathan Steinberg, MD, FACC; Margot Vloka, MD, FACC
Sponsor: St. Jude Medical
Contact: Edith Menchavez, RN, MA; Dr. Vloka - (212) 523-4007
Design: This is a multicenter, randomized clinical trial to evaluate two types of programming for the investigational ICD system (Photon DR) in patients who will need an ICD due to life-threatening rapid heart rhythms. Target number of subjects: 800 patients. Study duration: 2-3 years.
PAVE: Left Ventricular-Based Cardiac Stimulation Post AV-Node Ablation Evaluation
Principal Investigator: Jonathan Steinberg, MD, FACC
Sponsor: St. Jude Medical
Contact: Edith Menchavez, RN, MA; Dr. Steinberg - (212) 523-4007
Design: This is a multicenter, randomized clinical trial to evaluate the effects of 3 different kinds of pacing (right side, left side, or both sides of the heart) on exercise ability, quality of life and heart function in patients requiring a pacemaker after AV-Nodal ablation for atrial fibrillation. It uses an investigational pacemaker and lead system. Target number of subjects: 652 patients. Study duration: 2 years.
FAAT: Antiarrhythmic Effect of n-3 Fatty Acids in Patients with Implanted Cardiac Defibrillators (ICD)
Principal Investigator: Jonathan Steinberg, MD, FACC
Sponsor: National Institutes of Health
Contact: Ammy Alburo, RN; Dr. Steinberg - (212) 523-4007
Design: This is a multicenter, randomized clinical trial to evaluate the relative efficacy of fish oil vs. olive oil in preventing or reducing the occurrence of ventricular arrhythmias in patients with ICD. Both oils are normal dietary constituents and both have been claimed to have beneficial effects of the heart. Target number of subjects: 400. Study duration: 1-2 years
|
