Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) Post Approval Registry
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/27/2013 |
| Start Date: | March 2011 |
| End Date: | December 2013 |
| Contact: | Arthur J Moss, MD |
| Email: | heartajm@heart.rochester.edu |
| Phone: | 585-275-5391 |
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the
MADIT-CRT IDE study examining long-term mortality.
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.
Inclusion Criteria:
- Active patients who were enrolled in the MADIT-CRT IDE within the United States
Exclusion Criteria:
- Patients who are unable or unwilling to comply with the protocol requirements
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