Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : HM II (HeartMate II LVAD)
- drug : OMM (Optimal Medical Management)
Ages Eligible For Study:
- NYHA Class IIIB/IV (refer to Appendix IV for definitions) - Left ventricular ejection fraction (LVEF) ? 25% - Not currently listed for heart transplantation, and not planned in next 12 months - On optimal medical management - Limited functional status as demonstrated by 6MWT <300 meters - At least: - One hospitalization for HF in last 12 months or - At least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months