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

This study is currently recruiting participants.
Verified February 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01294449
First received: February 7, 2011
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Heart Failure
 Device: MADIT-CRT ICD
Device: MADIT-CRT CRT-D

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:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • All-Cause Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MADIT-CRT ICD Device: MADIT-CRT ICD
Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
Other Name: Market approved Boston Scientific implantable cardioverter defibrillators
MADIT-CRT CRT-D Device: MADIT-CRT CRT-D
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.

  Eligibility

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts
Contact: Arthur J Moss, MD 585-275-5391 heartajm@heart.rochester.edu

Locations
United States, New York
University of Rochester /Strong Memorial Recruiting
Rochester, New York, United States, 14642
Contact: Arthur J Moss, MD     585-275-5391     heartajm@heart.rochester.edu    
Principal Investigator: David Huang, MD            
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Arthur J Moss, MD University of Rochester Heart Research Follow-up Program
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01294449     History of Changes
Other Study ID Numbers: MADIT-CRT PAR
Study First Received: February 7, 2011
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013