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
  Purpose

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.


Condition Intervention
Heart Failure
Device: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
Device: MADIT-CRT ICD ONLY ARM

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 3 Years

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 36 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 447
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Market approved Boston Scientific implantable cardioverter defibrillators

  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 Europe.

Criteria

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

  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: NCT02060110

Locations
Israel
Israeli Association for Cardiovascular Trials at Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Israeli Association for Cardiovascular Trials - IACT
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Ilan Goldenberg, MD, Director of the Israeli Association for Cardiovascular Trials, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02060110     History of Changes
Other Study ID Numbers: SHEBA-12-9492-IG-CTIL
Study First Received: February 9, 2014
Last Updated: February 9, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
CRT
HEART FAILURE

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014