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

December 3, 2014 updated by: Boston Scientific Corporation

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

394

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
        • University of Rochester /Strong Memorial

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

Sampling Method

Probability Sample

Study Population

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

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MADIT-CRT ICD
Device: MADIT-CRT ICD
Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
Other Names:
  • 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 Names:
  • Boston Scientific market approved cardiac resynchronization therapy defibrillators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 5 years
Outcome measured for total population. Not broken down by indication received.
5 years

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Arthur J Moss, MD, University of Rochester Heart Research Follow-up Program

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

March 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADIT-CRT PAR

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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