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

November 30, 2018 updated by: Boston Scientific Corporation

Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1820

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Multiple locations in the US and international

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measured at average follow-up duration of 2.4 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time of event, DSMB review

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

University of Rochester

Investigators

  • Principal Investigator: Arthur J Moss, MD, University of Rochester, NY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clinicals0003
  • MADIT-CRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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