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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060110
• Other study ID #: SHEBA-12-9492-IG-CTIL
• Status: Completed
• Phase: N/A
• First received: February 9, 2014
• Last updated: February 9, 2014
• Start date: May 2010
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study

• MADIT-CRT ICD ONLY ARM

Locations

Country	Name	City	State
Israel	Israeli Association for Cardiovascular Trials at Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Israeli Association for Cardiovascular Trials - IACT

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		36 month follow-up	No
Secondary	Heart failure event or death	The combined end point of heart-failure or death, whichever came first.	36 month follow-up	No