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Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry (MADIT-CRT PAR)

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: February 7, 2011
Last updated: December 3, 2014
Last verified: March 2014

MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality.

(MADIT-CRT IDE: NCT00180271)

Condition Intervention
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • All-Cause Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Outcome measured for total population. Not broken down by indication received.

Enrollment: 394
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
Other Name: Market approved Boston Scientific implantable cardioverter defibrillators
Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
Other Name: Boston Scientific market approved cardiac resynchronization therapy defibrillators

Detailed Description:

The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The registry involves only those patients that participated in the MADIT-CRT IDE study within the United States.


Inclusion Criteria:

  • Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States

Exclusion Criteria:

  • Patients who are unable or unwilling to comply with the protocol requirements
  Contacts and Locations
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Please refer to this study by its identifier: NCT01294449

United States, New York
University of Rochester /Strong Memorial
Rochester, New York, United States, 14642
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Arthur J Moss, MD University of Rochester Heart Research Follow-up Program