Clinical trial NCT00146848: PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
Official title: Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 1742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Clinical Composite Score
timeFrame: From randomization (6-weeks) through 12-month visit
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: From randomization (6-weeks) through 12-month visit
measure: Change in Self Assessed Physical Activity
timeFrame: From randomization (6-weeks) through 12-month visit
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: David O. Martin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Utah Heart Clinic, LDS Hospital
name: John Day
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin DO, Stolen KQ, Brown S, Yu Y, Christie C, Doshi SK, Smith JM, Gold MR, Day JD. Pacing Evaluation-Atrial SUpport Study in Cardiac Resynchronization Therapy (PEGASUS CRT): design and rationale. Am Heart J. 2007 Jan;153(1):7-13. doi: 10.1016/j.ahj.2006.10.013.
citation: Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, Weiner S, Kraus SM, Stolen KQ, Gold MR. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1317-25. doi: 10.1111/j.1540-8167.2012.02402.x. Epub 2012 Jul 25.