PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
NCT ID: NCT00146848
Last Updated: 2011-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1742 participants
INTERVENTIONAL
2004-12-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
DDD-70
Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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David O. Martin, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
John Day
Role: PRINCIPAL_INVESTIGATOR
Utah Heart Clinic, LDS Hospital
Locations
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The Cleveland Clinic Hospital
Cleveland, Ohio, United States
Countries
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References
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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.
Other Identifiers
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PEGASUS
Identifier Type: -
Identifier Source: secondary_id
CR-CA-100604-H
Identifier Type: -
Identifier Source: org_study_id