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

This study has been completed.
Sponsor:
Collaborator:
Israeli Association for Cardiovascular Trials - IACT
Information provided by (Responsible Party):
Prof. Ilan Goldenberg, MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02060110
First received: February 9, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted

February 9, 2014
February 9, 2014
May 2010
September 2013   (final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 36 month follow-up ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Heart failure event or death [ Time Frame: 36 month follow-up ] [ Designated as safety issue: No ]
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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

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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP