PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1742.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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