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

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ClinicalTrials.gov Identifier: NCT00180271
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : June 2, 2011
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date February 23, 2011
Results First Posted Date June 2, 2011
Last Update Posted Date December 18, 2018
Study Start Date  ICMJE December 2004
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To determine whether CRT-D in high-risk coronary subjects will significantly reduce the combined endpoint of all-cause mortality or HF events when compared to ICD-only therapy, whichever comes first.
Change History Complete list of historical versions of study NCT00180271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
Recurrent Heart Failure Events [ Time Frame: Time of event, DSMB review ]
The MADIT-CRT secondary outcome evaluated the effects of CRT-D, relative to ICD, on the recurrence of heart failure events over the full study period 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • 1. Evaluate the effects of CRT-D, relative to ICD-only, on the changes from baseline to one year in ECHO-determined left ventricular internal volume at end systole with CRT therapy turned off during the one year echocardiogram.
  • 2. Evaluate the effects of CRT-D, relative to ICD-only, on the changes from baseline to one year in ECHO-determined left ventricular internal volume at end diastole with CRT therapy turned off during the one year echocardiogram.
  • 3. Evaluate the effects of CRT-D, relative to ICD-only, on the subject-specific rates of multiple HF events over the full study period.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
Official Title  ICMJE Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
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.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tachycardia
  • Congestive Heart Failure
Intervention  ICMJE
  • Device: Cardiac resynchronization therapy with defibrillation
    Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
  • Device: Implantable Cardioverter Defibrillator (ICD)
    Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
Study Arms
  • Experimental: CRT-D
    CRT-D: Cardiac resynchronization therapy with defibrillation.
    Intervention: Device: Cardiac resynchronization therapy with defibrillation
  • Active Comparator: ICD
    ICD: Implantable cardioverter defibrillator
    Intervention: Device: Implantable Cardioverter Defibrillator (ICD)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2005)
1820
Original Enrollment  ICMJE Same as current
Actual Study Completion Date September 2010
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00180271
Other Study ID Numbers  ICMJE Clinicals0003
MADIT-CRT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE University of Rochester
Investigators  ICMJE
Principal Investigator: Arthur J Moss, MD University of Rochester, NY
PRS Account Boston Scientific Corporation
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP