Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
- Conditions
- Heart Failure
- Interventions
- Device: MADIT-CRT ICDDevice: MADIT-CRT CRT-D
- Registration Number
- NCT01294449
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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)
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 394
- Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States
- Patients who are unable or unwilling to comply with the protocol requirements
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MADIT-CRT ICD MADIT-CRT ICD - MADIT-CRT CRT-D MADIT-CRT CRT-D -
- Primary Outcome Measures
Name Time Method All-Cause Mortality 5 years Outcome measured for total population. Not broken down by indication received.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Rochester /Strong Memorial
🇺🇸Rochester, New York, United States