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

Heart Failure Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03781258
Study type Interventional
Source Institute for Clinical and Experimental Medicine
Contact
Status Enrolling by invitation
Phase N/A
Start date November 23, 2018
Completion date December 31, 2021
View Details
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