PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT00146848

CR-CA-100604-H

PEGASUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,742 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices
• Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit
• Patients who are in sinus rhythm at the time of implant
• Patients who remain in the clinical care of the enrolling physician in approved centers
• Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy

Exclusion criteria

• Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing [DDD or DDDR]) and respective lower rate limits
• Patients with permanent atrial fibrillation or atrial flutter
• Patients who are in complete heart block
• Patients who have previously had a pacemaker, ICD, or CRT device
• Patients whose life expectancy is less than 12 months due to other medical conditions
• Patients who are expected to receive a heart transplant during the duration of the study
• Patients who have other cardiac surgeries or procedures planned but not yet performed
• Patients who currently have or who are likely to receive a tricuspid valve prosthesis
• Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study.
• Patients who are younger than 18 years of age
• Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
• Patients who are or become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,742 participants in 3 patient groups

DDD-40

Active Comparator group

Description:

DDD-40 for this trial is the comparator arm. Even though patients are receiving a CRT-D device, atrial support pacing in this arm will be limited as the device will not pace unless the rate falls below 40 bpm.

Treatment:

Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices

DDDR-40

Active Comparator group

Description:

DDDR-40 programming will initiate atrial support pacing if the rate falls below 40 bpm or if atrial support is needed in response to increased activity.

Treatment:

Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices

DDD-70

Active Comparator group

Description:

Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.

Treatment:

Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices