MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE

February 9, 2014 updated by: Prof. Ilan Goldenberg, MD, Sheba Medical Center
The registry is designed to determine the long-term mortality and morbidity 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 Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

447

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

  • Israel
      • Ramat Gan, Israel
        • Israeli Association for Cardiovascular Trials at Sheba Medical Center

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 Europe.

Description

Inclusion Criteria:

Active patients who were enrolled in the MADIT-CRT IDE within Europe

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 36 month follow-up
36 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure event or death
Time Frame: 36 month follow-up
The combined end point of heart-failure or death, whichever came first.
36 month follow-up

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Collaborators

Israeli Association for Cardiovascular Trials - IACT

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

May 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 9, 2014

First Submitted That Met QC Criteria

February 9, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 9, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9492-IG-CTIL

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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Conditions

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