Anti-thrombotic Monotherapy With the HeartMate 3 LVAS

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to obtain a single-center safety and feasibility data on patients managed with a single anti-thrombotic therapy and the incidence of thrombotic adverse events associated with HeartMate 3 LVAS therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Collaborator: Abbott
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy

• 6 months or more on reduced anti-coagulation regimen (target INR 1.5-1.9) free of thromboembolic and thrombotic complications

• 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 the speed optimization without a significant progression of heart failure based on a biomarker and complex clinical assessment follow-up

Exclusion Criteria:

• absence of an informed consent

• presence of any prosthetic valve

• known history of major thrombotic event e.g. 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

• any clinical indication for use of long-term warfarin anticoagulation (e.g. known genetic thrombotic mutation, malignancy)