Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tachycardia
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 1820
- Locations
- 1
- Primary Endpoint
- Mortality From Any Cause or First Heart Failure (HF) Event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
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.
- •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 = 0.30 by angiographic, radionuclide, or echocardiographic methods within one year prior to enrollment and measured during the enrollment echocardiogram obtained within 14 days prior to randomization to confirm eligibility (recommended)
- •Resting QRS duration \> or = 130 ms on print-out of a current electrocardiogram (ECG) obtained within 14 days prior to randomization.
Exclusion Criteria
- •Existing indication for CRT
- •Subjects with an implanted pacemaker
- •Subjects with an existing ICD or CRT device
- •Subjects in NYHA Class I with non-ischemic cardiomyopathy
- •Subjects in NYHA Class III or IV in the past 3 calendar months prior to, or at the time of, enrollment
- •Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 calendar months prior to enrollment
- •Enzyme-positive myocardial infarction within the past 3 calendar months prior to enrollment
- •Subjects with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
- •Subjects with second or third degree heart block
- •Subjects with irreversible brain damage from preexisting cerebral disease
Outcomes
Primary Outcomes
Mortality From Any Cause or First Heart Failure (HF) Event
Time Frame: Outcome measured at average follow-up duration of 2.4 years.
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: 1. administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or 2. administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.
Secondary Outcomes
- Recurrent Heart Failure Events(Time of event, DSMB review)