|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Boston Scientific Corporation |
|---|---|
| Collaborator: |
University of Rochester |
| Information provided by (Responsible Party): | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00180271 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Tachycardia Congestive Heart Failure |
Device: Cardiac resynchronization therapy with defibrillation Device: Implantable Cardioverter Defibrillator (ICD) |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy |
MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:
| Enrollment: | 1820 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CRT-D
CRT-D: Cardiac resynchronization therapy with defibrillation.
|
Device: Cardiac resynchronization therapy with defibrillation
Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
|
|
Active Comparator: ICD
ICD: Implantable cardioverter defibrillator
|
Device: Implantable Cardioverter Defibrillator (ICD)
Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ischemic heart disease defined as:
OR
AND all of the following:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Multiple locations in the US and international | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Arthur Moss, MD | University of Rochester |
More Information
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00180271 History of Changes |
| Other Study ID Numbers: | Clinicals0003, MADIT-CRT |
| Study First Received: | September 9, 2005 |
| Results First Received: | February 23, 2011 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Defibrillator Cardiac Resynchronization Therapy MADIT |
|
Heart Failure Tachycardia Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes |