Anti-thrombotic Monotherapy With the HeartMate 3 LVAS

Institute for Clinical and Experimental Medicine

Status: Unknown

Conditions: Cardiovascular Diseases; Heart Failure

Treatments: Drug: Warfarin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03704220

Version1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single anti-thrombotic treatment

Other group

Description:

Single anti-thrombotic treatment

Treatment:

Drug: Warfarin