Landmark Clinical Trials In Cardiac Rhythm Management

Boston Scientific is a worldwide leader in clinical research, seeking answers to improve patient management, clinical treatments, and patient quality-of-life. Boston Scientific has dedicated more than 15 years to arrhythmia and heart failure research and has thousands of patients in clinical and post-market surveillance studies.

The trials listed below represent landmark studies sponsored by Boston Scientific and by other leaders in clinical research.

The Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy (MADIT-CRT)

Sponsor: Boston Scientific
Purpose: To assess whether early intervention with CRT-D therapy can reduce the risk of mortality and heart failure events versus ICD therapy alone in NYHA Class II patients with ischemic or non-ischemic cardiomyopathy and in NYHA Class I patients with ischemic cardiomyopathy, left ventricular dysfunction, and prolonged intraventricular conduction
Trial Status: Ongoing; Enrollment completed April 2008
Learn more about MADIT-CRT

Sudden Cardiac Death In Heart Failure Trial (SCD-HeFT)

Sponsors: National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH), Wyeth-Ayerst, and Medtronic
Purpose: To determine if amiodarone or an implantable cardioverter defibrillator (ICD) reduces all-cause mortality in non-ischemic or ischemic patients on conventional medical therapy with NYHA II/III and ejection fraction (EF) ≤ 35%
Trial Completed: 2003
Learn more about SCD-HeFT

Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION)

Sponsor: Boston Scientific
Purpose: To study the effect of cardiac resynchronization therapy, with or without defibrillation, on death and hospitalization in heart failure patients when compared with optimal pharmacologic therapy
Trial Completed: 2002
Learn more about COMPANION
Learn about CRT cost-effectiveness in the COMPANION population

Multicenter Automatic Defibrillator Implantation Trial II (MADIT II)

Sponsor: Boston Scientific
Purpose: To evaluate the effects of prophylactic implantable cardioverter defibrillator therapy on survival in patients with prior myocardial infarction and left ventricular dysfunction
Trial Completed: 2001
Learn more about MADIT II

Multicenter Automatic Defibrillator Implantation Trial (MADIT)

Sponsor: Boston Scientific
Purpose: To determine whether prophylactic implantable cardioverter defibrillator therapy as compared with conventional medical therapy will improve survival in patients with prior myocardial infarction, unsustained ventricular tachycardia, and left ventricular dysfunction who are also at high risk for malignant ventricular arrhythmias.
Trial Completed: 1996
Learn more about MADIT