PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

Conditions
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Heart Failure

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DDD-40<br>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. | Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices<br>* 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.<br>|
| Active Comparator: DDDR-40<br>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. | Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices<br>* 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.<br>|
| Active Comparator: DDD-70<br>Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm. | Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Composite Score | 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. | From randomization (6-weeks) through 12-month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | 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. | From randomization (6-weeks) through 12-month visit | 
| Change in Self Assessed Physical Activity | 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. | From randomization (6-weeks) through 12-month visit |