MADIT-CRT TRIAL |
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Problem | Heart failure (NYHA I-II; EF < 30%; QRS > 130ms) |
Format | Double-blinded multi-center RCT |
Treatment | ICD-CRT |
Control | ICD only |
Population | 1820 patients |
Inclusion criteria | Patients of either sex who were at least 21 years of age could participate in the study if they had ischemic cardiomyopathy (NYHA class I or II) or nonischemic cardiomyopathy (NYHA class II only), sinus rhythm, an ejection fraction of 30% or less, and prolonged intraventricular conduction with a QRS duration of 130 msec or more. All eligible subjects met the guideline indication for ICD therapy. |
Exclusion criteria | Patients were excluded from enrollment for a variety of reasons, including an existing indication for CRT; having an implanted pacemaker, ICD, or resynchronization device; NYHA class III or IV symptoms, previous coronary-artery bypass grafting, percutaneous coronary intervention, or an enzyme-positive myocardial infarction within 3 months before enrollment; atrial fibrillation within 1 month before enrollment; |
Follow-up | Median 2.4 years |
Primary endpoint | Death from any cause or a nonfatal heart-failure event (whichever came first) |
Secondary endpoint(s) | - |
Details | 1820 patients with -ischaemic or non-ischaemic cardiomyopathy -ejection fraction of <30% -QRS duration of >130 msec -New York Heart Association class I or II |
Brief summary: | CRT (added to ICD) reduced CCF exasc in well low EF patients |
PAPER: Cardiac-resynchronization therapy for the prevention of heart-failure events. | |
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Date | 1 Oct 2009 |
Journal | N Engl J Med. 2009 Oct 1;361(14):1329-38. Epub 2009 Sep 1. |
Information | ICD-CRT (vs. ICD alone): -41% (significant) reduction in heart-failure exascerbations (ARR 8.9%) --Similar benefits for ischaemic & non-ischaemic cardiomyopathy -Significant reduction in LV volume & EF improvement -Similar risks of death (3%/yr) -Greatest benefit when QRS > 150ms |