MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy (MADIT-CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180271
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : June 2, 2011
Last Update Posted : January 30, 2012
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation

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).

Condition or disease Intervention/treatment Phase
Tachycardia Congestive Heart Failure Device: Cardiac resynchronization therapy with defibrillation Device: Implantable Cardioverter Defibrillator (ICD) Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
Study Start Date : December 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CRT-D
CRT-D: Cardiac resynchronization therapy with defibrillation.
Device: Cardiac resynchronization therapy with defibrillation
Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation

Active Comparator: ICD
ICD: Implantable cardioverter defibrillator
Device: Implantable Cardioverter Defibrillator (ICD)
Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Recurrent Heart Failure Events [ Time Frame: Time of event, DSMB review ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • Sinus rhythm by ECG (including right bundle branch block [RBBB] and first degree heart block with PR < 250 ms.)
  • Men and women 21 years of age or older (no upper-age cut off)

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
  • Women who are pregnant or plan to become pregnant during the course of the trial. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
  • Reversible non-ischemic cardiomyopathy such as acute viral myocarditis or discontinuation of alcohol in alcohol-induced heart disease
  • Subjects with chronic atrial fibrillation within one month prior to enrollment
  • Presence of any disease, other than the subject's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia (blood urea nitrogen [BUN] > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180271

United States, New York
Multiple locations in the US and international
Rochester, New York, United States, 14642
Sponsors and Collaborators
Boston Scientific Corporation
University of Rochester
Principal Investigator: Arthur Moss, MD University of Rochester

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation Identifier: NCT00180271     History of Changes
Other Study ID Numbers: Clinicals0003
First Posted: September 16, 2005    Key Record Dates
Results First Posted: June 2, 2011
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by Boston Scientific Corporation:
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes