PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Clinical Composite Score	From randomization (6-weeks) through 12-month visit	The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association \[NYHA\] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	From randomization (6-weeks) through 12-month visit	Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.
Change in Self Assessed Physical Activity	From randomization (6-weeks) through 12-month visit	Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.