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

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02060110
• Collaborator: Israeli Association for Cardiovascular Trials - IACT (Other)
• Enrollment: 447
• Location: 1
• Duration (Months): 44.1
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 447 participants
• Time Perspective: Prospective
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [36 month follow-up]

Secondary Outcome Measures

1. Heart failure event or death [36 month follow-up]

   The combined end point of heart-failure or death, whichever came first.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Israeli Association for Cardiovascular Trials at Sheba Medical Center	Ramat Gan		Israel

Sponsors and Collaborators

• Sheba Medical Center
• Israeli Association for Cardiovascular Trials - IACT

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.

• Responsible Party: Prof. Ilan Goldenberg, MD, Director of the Israeli Association for Cardiovascular Trials, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT02060110
• Other Study ID Numbers: SHEBA-12-9492-IG-CTIL
• First Posted: Feb 11, 2014
• Last Update Posted: Feb 11, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Prof. Ilan Goldenberg, MD, Director of the Israeli Association for Cardiovascular Trials, Sheba Medical Center: CRT; HEART FAILURE
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Feb 11, 2014