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

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180271
First received: September 9, 2005
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Mortality From Any Cause or First Heart Failure (HF) Event [ Time Frame: Outcome measured at average follow-up duration of 2.4 years. ] [ Designated as safety issue: Yes ]

    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:
  • Recurrent Heart Failure Events [ Time Frame: Time of event, DSMB review ] [ Designated as safety issue: No ]

Enrollment: 1820
Study Start Date: December 2004
Study Completion Date: September 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

OR

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180271

Locations
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
Investigators
Principal Investigator: Arthur Moss, MD University of Rochester
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180271     History of Changes
Other Study ID Numbers: Clinicals0003, MADIT-CRT
Study First Received: September 9, 2005
Results First Received: February 23, 2011
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Defibrillator
Cardiac Resynchronization Therapy
MADIT

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

ClinicalTrials.gov processed this record on November 25, 2014