Keywords:LVAD , Heart Failure , Transplantation , Destination Therapy , Artificial Heart , Bridge to Transplant
Sub Specialty: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
Enrollment in this study is limited to ambulatory, non-inotrope dependent, NYHA Class IIIB/IV HF patients, who are not currently listed for transplant, and meet the FDA approved indications for use for implantation of the HM II continuous flow LVAD for DT, and who either receive HM II LVAD support or continue with OMM.
At the time of enrollment, candidates will be considered regardless of gender, race or ethnicity; however, in order to qualify for inclusion in the study, the subject must meet the inclusion/exclusion criteria listed below.
1. Informed consent obtained.
2. Age between 18 - 85 years, inclusive.
3. NYHA Class IIIB or IV (refer to Appendix IV for definitions).
4. Left ventricular ejection fraction (LVEF) ≤ 25% as measured by the most recent echocardiogram within 45 days prior to enrollment.
5. Not currently listed for any organ transplant including heart transplantation, and not currently planned to be listed in next 12 months.
6. On optimal medical management (OMM):
a. Including ACE inhibitors or ARBs, beta-blockers and aldosterone antagonists for at least 45 out of the last 60 days,
b. Inability to tolerate neurohormonal antagonists (e.g. hypotension, worsening renal function).
7. Limited functional status as demonstrated by the most recent 6MWT distance < 300 meters within 45 days prior to enrollment (refer to Appendix II for Instructions).
8. At least:
a. One previous, unscheduled hospitalization for HF in last 12 months,
b. At least 2 previous unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months.
Subjects will be excluded from study participation for any one or more of the following:
1. Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis.
2. Most recent platelet count < 100,000/ml within 45 days prior to enrollment.
3. Any intravenous inotrope use within 30 days prior to enrollment.
4. Inability to perform 6MWT for any reason.
5. Psychiatric disease, irreversible cognitive dysfunction, poor psychosocial issues, or any other issue that is likely to impair compliance with the study protocol.
6. Any condition, other than heart failure, that could limit survival to less than 2 years.
7. History of cardiac or other organ transplant.
8. Existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment.
9. Presence of active, uncontrolled, systemic infection.
10. History of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis.
11. Contraindication to anticoagulation/antiplatelet therapy.
12. The most recent Estimated Glomerular Filtration Rate (eGFR) < 25ml/min using the Cockroft-Gault formula within 45 days prior to enrollment; or the need for acute or chronic renal replacement therapy (e.g. chronic dialysis) within 3 months prior to enrollment.
13. CRT or CRT-D implant or lead revision within 3 months prior to enrollment.
14. Coronary revascularization (e.g. CABG, PCI) within 3 months prior to enrollment.
15. Positive pregnancy test if of childbearing age at the time of enrollment.
16. Participation in any other clinical investigations involving another Mechanical Circulatory Support (MCS) device or heart failure related drug, or investigations that are likely to confound study results or affect study outcome.