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
Results First Received: February 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Tachycardia
Congestive Heart Failure
Interventions: Device: Cardiac resynchronization therapy with defibrillation
Device: Implantable Cardioverter Defibrillator (ICD)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study enrolled 1820 patients from 110 hospital centers (88 in the United States, 2 in Canada, and 20 in Europe) between December 22, 2004 and April 23, 2008. Follow-up continued thereafter until trial termination.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Data from all patients enrolled were analyzed on an intention-to-treat basis.

Reporting Groups
  Description
Cardiac Resynchronization Therapy + Defibrillator Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
Implantable Cardioverter Defibrillator Alone Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.

Participant Flow:   Overall Study
    Cardiac Resynchronization Therapy + Defibrillator     Implantable Cardioverter Defibrillator Alone  
STARTED     1089     731  
COMPLETED     1089     731  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cardiac Resynchronization Therapy + Defibrillator Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
Implantable Cardioverter Defibrillator Alone Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
Total Total of all reporting groups

Baseline Measures
    Cardiac Resynchronization Therapy + Defibrillator     Implantable Cardioverter Defibrillator Alone     Total  
Number of Participants  
[units: participants]
  1089     731     1820  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     543     380     923  
>=65 years     546     351     897  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 11     64  ± 11     65  ± 11  
Gender  
[units: participants]
     
Female     275     178     453  
Male     814     553     1367  
Region of Enrollment  
[units: participants]
     
United States     757     514     1271  
Canada     14     8     22  
Czech Republic     17     11     28  
Denmark     22     13     35  
France     13     9     22  
Germany     98     61     159  
Hungary     16     10     26  
Israel     45     30     75  
Italy     15     12     27  
Netherlands     34     24     58  
Poland     14     10     24  
Spain     36     24     60  
Switzerland     4     2     6  
United Kingdom     4     3     7  



  Outcome Measures

1.  Primary:   Mortality From Any Cause or First Heart Failure (HF) Event   [ Time Frame: Outcome measured at average follow-up duration of 2.4 years. ]

2.  Secondary:   Recurrent Heart Failure Events   [ Time Frame: Time of event, DSMB review ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The FDA Circulatory Devices advisory panel recommended approval for the patient subpopulation with left bundle branch block (LBBB) only. Consequently, FDA has restricted indications for use to LBBB.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Melchior
Organization: Boston Scientific
phone: 800 227 3422
e-mail: lisa.melchior@bsci.com


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:


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