Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 1,742
- Locations
- 1
- Primary Endpoint
- Clinical Composite Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DDD-40
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.
Intervention: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices (Device)
DDDR-40
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.
Intervention: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices (Device)
DDD-70
Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
Intervention: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices (Device)
Outcomes
Primary Outcomes
Clinical Composite Score
Time Frame: 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 Outcomes
- Change in Quality of Life(From randomization (6-weeks) through 12-month visit)
- Change in Self Assessed Physical Activity(From randomization (6-weeks) through 12-month visit)