Keywords: LVAD , Heart Failure , Transplantation , Destination Therapy , Artificial Heart , Bridge to Transplant
IRB Number: 00052434
Specialty: Cardiothoracic Surgery
Sub Specialties: Heart Failure
The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus OMM in ambulatory NYHA Class IIIB/IV HF patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.
It is expected that results from this study will be valuable in refining patient selection strategies for LVAD support, improving risk stratification models, and clarifying equipoise by determining advantages and disadvantages of LVAD therapy compared to medical management in appropriate populations of ambulatory HF patients.
The HM II LVAD cohort consists of subjects who meet study entrance criteria, including DT indications for use criteria, and electively choose to undergo HM II LVAD implantation.
The OMM cohort consists of subjects who meet study entrance criteria, including DT indications for use criteria, but who choose to continue on OMM per established advanced HF guidelines. Subjects in this cohort may subsequently receive a HM II LVAD at any point during the follow-up period; these subjects will be included in the delayed HM II LVAD cohort.
The surgical implantation of a HeartMate II LVAD is standard of care and FDA approved for patients with end-stage heart failure as is continuing to treat these patients with Optimal Medical Therapy. The only study-only related billable testing that patients will have while in this trial are a few laboratory tests. (see attached billing grid). These tests may be done either at the University Hospital or at the VA Medical Center in Salt Lake City and will be billed to the study. The non-billable personnel items (questionnaires, medical history forms) will be conducted by research coordinators in clinic at the University of Utah Hospital. All other care and testing given to a patient participating in this study is standard of care for heart failure patients.
Evaluate & compare effectiveness of HMII LVAD support vs. Optimal Medical Management in ambulatory NYHA Class IIIB/IV Heart Failure pts who are not dependent on IV inotropic support and who meet the FDA approved indications for HM II LVAD DT.
Principle Investigator: Craig Selzman
Principle Department: Cardiothoracic Divison