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

Sheba Medical Center

Status: Completed

Conditions: Heart Failure

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

Study type: Observational

Funder types: Other

Identifiers

NCT02060110

SHEBA-12-9492-IG-CTIL

Details and patient eligibility

About

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.

Enrollment: 447 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

447 participants in 2 patient groups

MADIT-CRT CRT-D

Description:

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

Treatment:

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

MADIT-CRT ICD

Description:

Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study

Treatment:

Device: MADIT-CRT ICD ONLY ARM