Table 1.

Clinical trial summary

Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3)
Trial design	International, prospective, randomized, double‐blind, placebo‐controlled non‐inferiority clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist (INR 2.0–3.0) with aspirin (100 mg) vs. vitamin K antagonist (INR 2.0–3.0) with placebo. Randomizing 628 patients at up to 50 centres worldwide (in the United States, Canada, United Kingdom, Europe, Kazakhstan, and Australia).
Objective	To study the safety and efficacy of an antiplatelet‐free antithrombotic regimen in patients with advanced heart failure treated with the HM3 left ventricular assist system.
Hypothesis	Withdrawal of antiplatelet therapy from the antithrombotic regimen of HM3 pump patients will not adversely affect safety or efficacy of the HM3 and may reduce non‐surgical bleeding.
Primary endpoint	The composite of survival free of any non‐surgical1 major haemocompatibility‐related adverse event2 at 1 year post‐implant. Non‐surgical is defined as any event occurring >14 days post‐implant. Major haemocompatibility‐related adverse events include: Stroke Pump thrombosis (suspected or confirmed) Bleeding (including intracranial bleeds that do not meet the stroke definition) Arterial peripheral thromboembolism.
Secondary endpoints	Secondary endpoints, listed below, will be analysed separately to provide context to each of the components of the composite primary endpoint: Non‐surgical major haemorrhagic events Non‐surgical major thrombotic events Survival Stroke rates Pump thrombosis rates Bleeding rates, including: ◦ Non‐surgical bleeding ◦ Moderate bleeding ◦ Severe bleeding ◦ Fatal bleeding ◦ Gastrointestinal bleeding.
Descriptive endpoints	Changes in the haemocompatibility score, rehospitalization, and economic cost implications.

HM3, HeartMate 3.