Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)

Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study

The purpose of this prospective controlled study is to obtain a multi-center safety and feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.

Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.

Inclusion Criteria:

• patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy
• a minimum of 6 months since HeartMate3 LVAS implantation free of thromboembolic events and pump malfunction
• evidence of forward flow across the aortic valve (with aortic valve opening of at least 1:2 per cardiac cycle) at baseline echocardiography (ECHO) or after speed reduction as long as no evidence of progression of heart failure is noted, based on a combination of biomarkers and clinical assessment follow-up (see Appendix III); Clinical assessment will include review of the biomarkers, invasive or non-invasive hemodynamics (as available or indicated) and clinical physical examination

Exclusion Criteria:

• absence of an informed consent
• presence of any prosthetic valve or central aortic valve repair (e.g. Park's stitch)
• presence of any other ancillary circulatory assist device system
• known history of major thrombotic event e.g. deep vein thrombosis (DVT)
• known history of stroke
• left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant
• evidence of any intracardiac thrombus evidenced by transoesophageal echocardiography
• any other clinical indication for a use of long-term anticoagulation using a vitamin K antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation mandating the therapy, malignancy)