MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy — MADIT-CRT  

Congestive Heart Failure Clinical Trial

Official title: Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy

Status Completed

Clinical Trial Summary

The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart failure (HF) events by approximately 25%, in subjects who are in New York Heart Association (NYHA) functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are in NYHA functional Class I with ischemic cardiomyopathy, left ventricular dysfunction (ejection fraction [EF] < or = 0.30), and prolonged intraventricular conduction (QRS duration > or = 130 ms).

Clinical Trial Description

In this study, subjects will be randomized to CRT-D or ICD-only. Randomization will be stratified by clinical center and ischemic status. Approximately 60% of the subjects will be randomly assigned to receive a CRT-D with biventricular pacing, and 40% will receive an ICD only. Optimal pharmacological therapy for heart failure will be required in both treatment arms. Length of follow-up for each subject will depend on the date of entry into the study, since all subjects will be followed to a common study termination date. ;

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Tachycardia

• NCT number: NCT00180271
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Completion date: September 2010