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MADIT-CRT Trial Design

Sponsored by Boston Scientific

80% of ICD and CRT-D patients came from the same place.The Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy (MADIT-CRT) is the largest randomized, NYHA Class
I/II CRT-D trial to date, with over 1800 patients enrolled at 110 centers in 14 countries. MADIT-CRT is designed to assess whether early intervention with CRT can slow the progression of heart failure.

Like MADIT and MADIT II, the MADIT-CRT trial is being sponsored by Boston Scientific and conducted under the leadership of principal investigator Dr. Arthur J. Moss, Professor of Medicine at the University of Rochester.

Hypothesis and Endpoint

The MADIT-CRT trial was designed to evaluate if CRT-D therapy will reduce the risk of mortality and heart failure events in subjects who are in 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 (EF ≤ 0.30) and prolonged intraventricular conduction (QRS duration ≥ 130 ms).

The MADIT-CRT primary endpoint is death from any cause or first heart failure (HF) event, whichever comes first.

Protocol


Patients are randomized to CRT-D or ICD-only. Randomization is stratified by clinical center and ischemic status.
Approximately 60% of the subjects are randomly assigned to receive a CRT-D with biventricular pacing, and 40% to receive an ICD only.
Optimal pharmacological therapy for heart failure is 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.

Enrollment

1820 patients are randomized at 110 centers in 14 countries.

Inclusion Criteria

Ischemic heart disease, defined as:
NYHA Class I or II for the 3 months prior to and at enrollment
Prior MI > 3 months prior to enrollment and / or
One or more prior CABG or percutaneous coronary interventions > 3 months prior to enrollment

OR

Non-ischemic heart disease, including dilated cardiomyopathy characterized by a low EF and increased ventricular volume with ventricular compliance that is normal or increased
NYHA Class II for the 3 months prior to and at enrollment

AND

Stable optimal pharmacologic therapy
EF ≤ 0.30 and QRS ≥ 130 ms documented and confirmed within 2 weeks of randomization
Sinus rhythm by ECG
≥ 21 years

Major Exclusion Criteria

Patients with a pacemaker, ICD, or CRT device or who are presently indicated for
a CRT-D
NYHA Class I with non-ischemic cardiomyopathy or NYHA Class III or IV within the past 3 months or at the time of enrollment
CABG or percutaneous coronary intervention within the past 3 months or a candidate for these procedures in the foreseeable future
Enzyme-positive MI within the past 3 months
Second or third degree heart block
Chronic atrial fibrillation within 1 month prior to enrollment

More Information

For more information about the MADIT-CRT trial, including updates to trial status, visit the MADIT-CRT page at ClinicalTrials.gov , a service of the U.S. National Institutes of Health.

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Recent Updates

Dr. Moss presented MADIT-CRT preliminary results at European Society of Cardiology (ESC)
Click here to access slides hosted on the ESC website »

View and print The New England Journal of Medicine article »

MADIT-CRT Trial Reached Primary Endpoint » Preliminary results show CRT-D therapy is associated with a significant 34 percent reduction (p=0.001) in death or first heart failure intervention when compared to ICD therapy alone.