Anti-thrombotic Monotherapy With the HeartMate 3 LVAS

Not Applicable

• Conditions: Cardiovascular Diseases; Heart Failure
• Interventions: Drug: Warfarin

• Registration Number: NCT03704220
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief 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.

Detailed Description

Patients implanted with the HeartMate 3 LVAS in whom at least 6 months reduced anticoagulation therapy (INR range 1.5-1.9 along with antiplatelet therapy) has been accomplished safely will be screened for participation in the study. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) and anticoagulation with warfarin will be removed. 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 endpoint will be analyzed at 90 days after initiation of the single antiplatelet therapy.

Study Timeline

• Study Start: 2018-08-16
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-01
• Last Update Posted: 2020-08-04
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single anti-thrombotic treatment	Warfarin	Single anti-thrombotic treatment

Primary Outcome Measures

Name	Time	Method
survival free rate of thromboembolic events	90 days	Determination of survival free of thromboembolic events (i.e. pump thrombosis or any ischemic stroke) using only a single antithrombotic therapy with Acetylsalicylic Acid.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	90 days	Adverse events rates per INTERMACS definitions.

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Prague 4, Czechia