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

Completed

• Conditions: Heart Failure
• Interventions: 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

• Registration Number: NCT02060110
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-09
• Study Completion: 2014-01
• Status Verified: 2014-02
• Study First Submitted: 2014-02-09
• Study First Submitted QC: 2014-02-09
• Last Update Submitted: 2014-02-09
• Study First Posted: 2014-02-11
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

Active patients who were enrolled in the MADIT-CRT IDE within Europe

Read More

Exclusion Criteria

Patients who are unable or unwilling to comply with the protocol requirements

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MADIT-CRT CRT-D	Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study	Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
MADIT-CRT ICD	MADIT-CRT ICD ONLY ARM	Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study

Primary Outcome Measures

Name	Time	Method
All-cause mortality	36 month follow-up

Secondary Outcome Measures

Name	Time	Method
Heart failure event or death	36 month follow-up	The combined end point of heart-failure or death, whichever came first.

Trial Locations

Locations (1)

Israeli Association for Cardiovascular Trials at Sheba Medical Center; 🇮🇱 Ramat Gan, Israel