PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)

Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices

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 Type: Interventional
• Enrollment (Actual): 1742
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices; 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.
Active Comparator: 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.	Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices; 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.
Active Comparator: DDD-70; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: David O. Martin, MD, MPH, The Cleveland Clinic; Principal Investigator: John Day, Utah Heart Clinic, LDS Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimate): September 7, 2005

Study Record Updates

• Last Update Posted (Estimate): December 28, 2011
• Last Update Submitted That Met QC Criteria: December 20, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR-CA-100604-H; PEGASUS