Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry (MADIT-CRT PAR)

Boston Scientific

Status: Completed

Conditions: Heart Failure

Treatments: Device: MADIT-CRT CRT-D; Device: MADIT-CRT ICD

Study type: Observational

Funder types: Industry

Identifiers

NCT01294449

MADIT-CRT PAR

Details and patient eligibility

About

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)

Full description

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).

Enrollment: 394 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

394 participants in 2 patient groups

MADIT-CRT ICD

Treatment:

Device: MADIT-CRT ICD

MADIT-CRT CRT-D

Treatment:

Device: MADIT-CRT CRT-D