NCT00180271

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

Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,820 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Tachycardia
• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	Cardiac resynchronization therapy with defibrillation	Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
DEVICE	Implantable Cardioverter Defibrillator (ICD)	Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator

Timeline

• Start date: 2004-12-01
• Primary completion: 2009-06-01
• Completion: 2010-09-01
• First posted: 2005-09-16
• Last updated: 2018-12-19
• Results posted: 2011-06-02

Locations

1 site across 1 country: United States