PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00146848
First received: September 2, 2005
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Clinical Composite Score [ Time Frame: From randomization (6-weeks) through 12-month visit ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Quality of Life [ Time Frame: From randomization (6-weeks) through 12-month visit ] [ Designated as safety issue: No ]
    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.

  • Change in Self Assessed Physical Activity [ Time Frame: From randomization (6-weeks) through 12-month visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 1742
Study Start Date: December 2004
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146848

Locations
United States, Ohio
The Cleveland Clinic Hospital
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David O. Martin, MD, MPH The Cleveland Clinic
Principal Investigator: John Day Utah Heart Clinic, LDS Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00146848     History of Changes
Other Study ID Numbers: CR-CA-100604-H, PEGASUS
Study First Received: September 2, 2005
Results First Received: February 28, 2010
Last Updated: December 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014