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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02060110
First Posted: February 11, 2014
Last Update Posted: February 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Israeli Association for Cardiovascular Trials - IACT
Information provided by (Responsible Party):
Prof. Ilan Goldenberg, MD, Sheba Medical Center
February 9, 2014
February 11, 2014
February 11, 2014
May 2010
September 2013   (Final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 36 month follow-up ]
Same as current
No Changes Posted
Heart failure event or death [ Time Frame: 36 month follow-up ]
The combined end point of heart-failure or death, whichever came first.
Same as current
Not Provided
Not Provided
 
MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE
Not Provided
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.
Not Provided
Observational [Patient Registry]
Time Perspective: Prospective
3 Years
Not Provided
Probability Sample
The registry involves only those patients that participated in the MADIT-CRT IDE study within Europe.
Heart Failure
  • Device: 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
  • Device: MADIT-CRT ICD ONLY ARM
    Other Name: Market approved Boston Scientific implantable cardioverter defibrillators
  • MADIT-CRT CRT-D
    Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
    Intervention: Device: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
  • MADIT-CRT ICD
    Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study
    Intervention: Device: MADIT-CRT ICD ONLY ARM
 
Completed
447
January 2014
September 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02060110
SHEBA-12-9492-IG-CTIL
No
Not Provided
Not Provided
Prof. Ilan Goldenberg, MD, Sheba Medical Center
Sheba Medical Center
Israeli Association for Cardiovascular Trials - IACT
Not Provided
Sheba Medical Center
February 2014