NCT01294449

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	MADIT-CRT ICD	Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
DEVICE	MADIT-CRT CRT-D	Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2011-02-11
• Last updated: 2014-12-04
• Results posted: 2014-12-04

Locations

1 site across 1 country: United States