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Completed

NCT Number: NCT00146848

PEGASUS CRT Study: 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Cleveland Clinic Hospital

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. 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

  1. Change in Quality of Life

    Time frame: 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.

  2. Change in Self Assessed Physical Activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

Acronym: PEGASUS CRT

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 7, 2005
Registry last updated
Dec 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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