Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

Boston Scientific Corporation394 enrolled

Overview

MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)

The registry is designed to determine the long-term mortality 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 the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).

Study Type

OBSERVATIONAL

Enrollment

394

Conditions

Heart Failure

Interventions

MADIT-CRT ICDDEVICE

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

MADIT-CRT CRT-DDEVICE

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States Exclusion Criteria: * Patients who are unable or unwilling to comply with the protocol requirements

Locations (1)

University of Rochester /Strong Memorial

Rochester, New York, United States

Outcomes

Primary Outcomes

All-Cause Mortality

Outcome measured for total population. Not broken down by indication received.

Time frame: 5 years

Data from ClinicalTrials.gov

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