At a glance
ClinicalIndex Comparison Record- ✓Ischemic heart disease with NYHA Class I–II for ≥3 months and prior MI (Q-wave or enzyme-positive), CABG, or PCI (but not within 3 months of enrollment)
- ✓Non-ischemic cardiomyopathy with NYHA Class II for ≥3 months, low EF, and increased ventricular volume
- ✓Ejection fraction ≤30% confirmed within 14 days prior to randomization
- ✓QRS duration ≥130 ms on ECG within 14 days prior to randomization
- ✕Existing indication for CRT or implanted pacemaker/ICD/CRT device
- ✕NYHA Class I with non-ischemic cardiomyopathy or NYHA Class III–IV within 3 months
- ✕Recent coronary revascularization or enzyme-positive MI within 3 months of enrollment
- ✕Candidate for coronary revascularization likely to undergo CABG or PCI in foreseeable future
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
In Brief
A clinical study evaluating Cardiac resynchronization therapy with defibrillation and Implantable Cardioverter Defibrillator (ICD) for Tachycardia and Congestive Heart Failure. Completed, enrolled 1,820 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator