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

Study Overview
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Brief Summary
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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.

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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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

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

Conditions
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Heart Failure, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model 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 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 endpoint will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anit-thrombotic monotherapy<br>Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA). | Drug: Warfarin<br>* Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival free of a pump malfunction due to thrombosis or any ischemic stroke | To determine survival free of a pump malfunction due to thrombosis or any ischemic stroke at 90-days (primary safety end point) and at 180-days (primary efficacy end point) in patients implanted with HeartMate 3 LVAS after transition to a single antithrombotic with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions. | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical circulatory support, Anti-thrombotic monotherapy