N/A
N=1,820
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
Tachycardia · Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00180271 ↗Enrolled (actual)
1,820
Serious AEs
12.2%
Results posted
Jun 2011
Primary outcome: Primary: Mortality From Any Cause or First Heart Failure (HF) Event — 901; 543; 188; 188 Participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiac resynchronization therapy with defibrillation (Device); Implantable Cardioverter Defibrillator (ICD) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality From Any Cause or First Heart Failure (HF) Event |
901; 543; 188; 188; 152; 170 | < 0.001 sig |
| SECONDARY Recurrent Heart Failure Events |
928; 545; 93; 107; 68; 79 | 0.001 sig |
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 = 130 ms).
Eligibility Criteria
Inclusion Criteria
- Ischemic heart disease defined as:
- NYHA Class I or II for the past 3 calendar months prior to, and at the time of, enrollment;
- one or more clinically documented (Q wave or enzyme positive) prior myocardial infarctions, but not within 3 calendar months of enrollment; and/or
- one or more prior coronary artery bypass graft surgeries or percutaneous coronary interventions (balloon and/or stent angioplasty) but not within 3 calendar months of enrollment.
OR
- Non-ischemic heart disease including dilated cardiomyopathy characterized by a low ejection fraction and increased ventricular volume, with ventricular compliance that is normal or increased
- NYHA Class II for the past 3 calendar months prior to, and at the time of, enrollment
AND all of the following:
- Stable optimal pharmacologic therapy.
- An ejection fraction or = 130 ms on print-out of a current electrocardiogram (ECG) obtained within 14 days prior to randomization.
- Sinus rhythm by ECG (including right bundle branch block [RBBB] and first degree heart block with PR 70 mg/dl or creatinine > 3.0 mg/dl), liver failure, etc.
- Subjects participating in any other clinical trials
- Subjects unwilling or unable to cooperate with the protocol
- Subjects who live at such a distance from the clinic that travel for follow-up visits would be unusually difficult
- Subjects who do not anticipate being residents of the area for the scheduled duration of the trial
- Subjects unwilling to sign the consent for participation
Data sourced from ClinicalTrials.gov (NCT00180271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.