Status:
COMPLETED
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
1742 Patients enrolled
Trial Details
Trial ID
NCT00146848
Start Date
December 1 2004
End Date
February 1 2009
Last Update
December 28 2011
Active Locations (1)
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1
The Cleveland Clinic Hospital
Cleveland, Ohio, United States, 44195