Table 6.

Key completed and ongoing trials in LVAD patients.

Study	Device	Indication	Patients	Trial Design	Results
REMATCH [32]	HeartMate XVE	DT, transplant-ineligible	NYHA class IV, LVEF ≤25%, VO2 <12 ml/kg-min or inotrope dependent	RCT, 1:1 to HM XVE vs. OMM	48% reduction in death with LVAD compared to OMM (p=0.001)
HeartMate II BTT [51]	HeartMate II	BTT	NYHA class IV, status 1A or 1B for transplant	Non-randomized	75% of patients were listed, eligible for listing or recovered at 180 days
HeartMate II DT [52]	HeartMate II	DT, transplant-ineligible	NYHA class IIIB or IV, LVEF ≤25%, VO2 ≤14 ml/kg-min or <50% predicted	RCT, 2:1 to HM II or HM XVE	46% of HM II patients alive at 2 yrs free of disabling stroke or reoperation vs 11% for HM XVE (p<0.001)
ADVANCE [53]	HeartWare HVAD	BTT	NYHA class IV, status 1A or 1B for transplant	Non-randomized vs historical controls	92% of HVAD vs 90% of controls alive or transplanted at 180 days (p<0.001)
*ROADMAP [54]	HeartMate II	DT	NYHA class IIIB/IV, LVEF ≤25%, not listed for transplant, no recent inotrope	HM II vs OMM	Primary EP = composite of survival with improvement in 6MWT from baseline at 1 yr
*REVIVE-IT [55]	HeartMate II	Chronic heart failure	Ambulatory, NYHA class III, LVEF ≤35%, no recent inotrope	RCT, 1:1 to HM II or OMM	Primary EP = composite of survival, freedom from stroke, improvement in 6MWT at 2 yrs
*Jarvik 2000 Heart BTT [56]	Jarvik 2000 Ventricular Assist System	BTT	Inotrope- or balloon pump-dependent UNOS status 1A or 1B	Open-label efficacy study	Primary EP = survival to transplant or survival and listed for transplant at 180 days

^*Trials not yet completed or results not yet available

Abbreviations: BTT – bridge-to-transplant, DT – destination therapy, EP – endpoint, LVEF – left ventricular ejection fraction, NYHA – New York Heart Association, OMM – optimal medical management, RCT – randomized controlled trial, 6MWT – 6-minute walk test.