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

N/ACompletedNCT02060110

Sheba Medical Center447 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

447

Conditions

Heart Failure

Interventions

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

MADIT-CRT ICD ONLY ARMDEVICE

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Israeli Association for Cardiovascular Trials at Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

All-cause mortality

Time frame: 36 month follow-up

Secondary Outcomes

Heart failure event or death

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

Time frame: 36 month follow-up

Data from ClinicalTrials.gov

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