Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01294449
First received: February 7, 2011
Last updated: March 3, 2014
Last verified: March 2014
  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:


Further study details as provided by Boston Scientific Corporation:

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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294449

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