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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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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