Clinical Trials
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. 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.
Clinical trials are frequently sponsored by the National Institute of Health, but other scientific organizations or industrial entities may sponsor and support these trials. Trials may make available newer or innovative procedures or treatments not yet approved for general usage.
As a leading academic institution, and component of Columbia University, The Arrhythmia Institute of The Valley Hospital is a leader in the design, conduct, and interpretation of clinical trials for the care of arrhythmia patients.
Below you will find a listing of our currently active clinical trial programs.
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St. Luke's & Roosevelt Hospitals Device Trials
ECHO-CRT - Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation
Principal Investigator: Suneet Mittal, MD
Sponsor: Biotronik
Purpose: To determine if resynchronization therapy benefits patients with narrow QRS
Eligibility:
Class III heart failure
Must be a candidate to receive an implantable cardiac defibrillator (ICD)
Not eligible for CRT
Description:
All subjects will have a third lead (CRT) placed at the time of ICD implant. Subjects will then be randomized to CRT on or CRT off. If subjects develop a reason the CRT is required, CRT may be turned on.
REVERT - Randomized Study of Endovascular versus Epicardial Lead Placement for Resynchronization Therapy
Principal Investigator: Jonathan Steinberg, MD
Sponsor: Medtronic
Purpose: To determine the comparative efficacy of surgical vs. transvenous placement of left ventricular leads for resynchronization therapy
Eligibility:
Class III-IV heart failure
Require cardiac resynchronization therapy (CRT)
Upgrade from pacemaker to CRT
Description:
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 surgical placement of the left ventricular lead. This study is comparing the best position for optimizing CRT.
Safety of Sports for Patients with Implantable Cardioverter Defibrillators.
Principal Investigator: Merle Myerson, MD
Sponsor: Yale University
Purpose: To determine if shocks from defibrillators occur during physical activities
Eligibility:
Must already have a defibrillator implanted
Must be participating in competitive sports
Description:
This is a registry documenting when patients receive device therapy or shocks.
DETERMINE - Registry Arm & Randomized Arm Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation
Principal Investigator: Suneet Mittal, MD
Sponsor: St. Jude Medical
Purpose: To determine if the ICD reduces death rates in patients with MI scar but relatively preserved cardiac function
Eligibility:
Coronary artery disease
Left ventricular ejection fraction of 35% or higher
Description:
Subjects with coronary artery disease (CAD) and ejection fraction of 35% or higher and will undergo a contrast enhanced MRI and will be enrolled in a registry. Subjects with infarct mass of 15% or greater will be randomized to ICD therapy or standard medical therapy.
BLOCK HF - Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block
Principal Investigator: Suneet Mittal, MD
Sponsor: Medtronic
Purpose: To determine if resynchronization therapy reduces the risk of heart failure in patients who require continuous pacing
Eligibility:
Subjects with congestive heart failure NYHA Class I, II or III
Left ventricular dysfunction of 50% or less
Atrio-ventricular block
Description:
Eligible patients will receive a cardiac resynchronization therapy (CRT) defibrillator or CRT pacemaker and will be randomized to either conventional right ventricular pacing (RV) or biventricular pacing (BiV).
MADIT-RIT - Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy
Principal Investigator: Aysha Arshad, MD
Sponsor: Boston Scientific
Purpose: To identify the ideal technique to prevent inappropriate shocks from the ICD
Eligibility:
Subjects who are 21 years and older and are implanted with a Boston Scientific CRT-D or ICD.
Description:
This study compares different standard methods of device programming (with high rate cutoff and/or long delay) to reduce inappropriate therapies.
St. Luke's & Roosevelt Hospitals Atrial Fibrillation Trials
AFIB-CRT - The Effect of Biventricular Pacing on the Incidence of Atrial Fibrillation
Principal Investigator: Tina Sichrovsky, MD
Sponsor: Boston Scientific
Purpose: To evaluate the effect of CRT on the incidence of atrial fibrillation in ICD and pacemaker device patients upgraded to CRT.
Eligibility:
Must already have a dual chamber pacemaker or ICD implanted for at least one year
CRT indication
Description:
Subjects with a dual chamber ICD or pacemaker implanted for at least a year undergoing a CRT-D upgrade will be eligible for the study.
PUFFER - Pulmonary Vein Isolation Outcomes with Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Fish Oil
Principal Investigator: Suneet Mittal, MD
Sponsor: GlaxoSmithKline
Purpose: To determine if fish oil will reduce the amount of atrial fibrillation post ablation.
Eligibility:
Atrial fibrillation
Pulmonary vein isolation procedure planned
Description:
People requiring pulmonary vein isolation ablation for atrial fibrillation will be asked to take fish oil (LOVAZA) or a matching placebo for 6 to 12 weeks prior to the ablation.
CABANA - The Catheter Ablation Versus Antiarrhythmic Drug Therapy for
Atrial Fibrillation
Principal Investigator: Mark Preminger, MD
Sponsor: National Institutes of Health
Purpose: To determine if catheter ablation of atrial fibrillation reduces the risk of death or stroke compared to conventional medical therapy
Eligibility:
Subjects with new onset or under-treated atrial fibrillation
Either paroxysmal atrial fibrillation or long standing persistent atrial fibrillation
Description:
This study has two groups, one treated with medication and the second treated with primary catheter ablation.
PV ABLATION – QOL - Post Pulmonary Vein Ablation Quality of Life
Principal Investigator: Tina Sichrovksy, MD
Sponsor: St. Luke’s and Roosevelt Hospitals
Purpose: To assess changes in quality of life (QOL) in patients who have undergone pulmonary vein ablation for atrial fibrillation.
Eligibility:
Patients who undergo pulmonary veins isolation for treatment of atrial fibrillation
Description:
Patients will complete questionnaires before and after the ablation procedure.
The Valley Hospitals Device Trials
DETERMINE - Registry Arm & Randomized Arm Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation
Principal Investigator: Suneet Mittal, MD
Sponsor: St. Jude Medical
Purpose: To determine if the ICD reduces death rates in patients with MI scar but relatively preserved cardiac function
Eligibility:
Coronary artery disease
Left ventricular ejection fraction of 35% or higher
Description:
Subjects with coronary artery disease (CAD) and ejection fraction of 35% or higher and will undergo a contrast enhanced MRI and will be enrolled in a registry. Subjects with infarct mass of 15% or greater will be randomized to ICD therapy or standard medical therapy
IMPACT - The Impact of Biotronik Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with Implanted Cardioverter Defibrillators and CRT-D devices
Principal Investigator: Suneet Mittal, MD
Sponsor: Biotronik
Purpose: To determine if early awareness of an abnormal heart rhythm with Home Monitoring in combination with anticoagulation (blood thinning) medication is able to reduce the risk of stroke in patients implanted with dual-chamber ICDs or CRT-Ds.
Eligibility:
Subjects with standard indications for dual chamber ICD or CRT-D implantation
Description:
Patients are followed by Home Monitoring or standard office visits.
MADIT-RS - Risk Stratification in MADIT II Type Patients
Principal Investigator: Aysha Arshad, MD
Sponsor: National Institutes of Health
Purpose: To determine what clinical and ECG factors identify patients at risk for cardiac events (heart rhythm disturbances requiring therapy by implantable cardioverter defibrillator or death) in patients after heart attack with impaired heart function.
Eligibility:
Subjects with ICD implanted based on MADIT II criteria
Description:
Patients will undergo a battery of noninvasive tests prior to, or soon after, ICD placment.
MADIT-RIT - Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy
Principal Investigator: Aysha Arshad, MD
Sponsor: Boston Scientific
Purpose: To identify the ideal technique to prevent inappropriate shocks from the ICD
Eligibility:
Subjects who are 21 years and older and are implanted with a Boston Scientific CRT-D or ICD.
Description:
This study compares different standard methods of device programming (with high rate cutoff and/or long delay) to reduce inappropriate therapies.
The Valley Hospitals Atrial Fibrillation Trials
AFIB-CRT - The Effect of Biventricular Pacing on the Incidence of Atrial Fibrillation
Principal Investigator: Tina Sichrovsky, MD
Sponsor: Boston Scientific
Purpose: To evaluate the effect of CRT on the incidence of atrial fibrillation in ICD and pacemaker device patients upgraded to CRT.
Eligibility:
Must already have a dual chamber pacemaker or ICD implanted for at least one year
CRT indication
Description:
Subjects with a dual chamber ICD or pacemaker implanted for at least a year undergoing a CRT-D upgrade will be eligible for the study.
PV ABLATION – QOL - Post Pulmonary Vein Ablation Quality of Life
Principal Investigator: Tina Sichrovksy, MD
Sponsor: St. Luke’s and Roosevelt Hospitals
Purpose: To assess changes in quality of life (QOL) in patients who have undergone pulmonary vein ablation for atrial fibrillation.
Eligibility:
Patients who undergo pulmonary veins isolation for treatment of atrial fibrillation
Description:
Patients will complete questionnaires before and after the ablation procedure.
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