NCT00146848

PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,742 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.

Detailed description

PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients. The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices	All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.

Timeline

• Start date: 2004-12-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2005-09-07
• Last updated: 2011-12-28
• Results posted: 2010-09-23

Locations

1 site across 1 country: United States