MAGENTUM 1 HeartMate 3 LVAS: A Single Center Prospective Controlled Study (MAGENTUM 1)

Study Overview
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Brief Summary
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The purpose of this study is to obtain single-center safety and feasibility data on patients managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse events associated with the HeartMate 3 LVAS therapy.

Detailed Description
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Patients with implanted HeartMate 3 device will be bridged with heparin until target International Normalized Ratio (INR) of 2,0 - 3,0 will be reached on anticoagulation therapy with Warfarin. Along with Warfarin, Acetylsalicylic Acid (ASA) will be administered in dose of 100mg per day. Enrollment for the study will take place in 1-6 weeks post implant of HeartMate 3. Low-intensity anticoagulation protocol will be started at 6 weeks after implant. Target INR of 1,5-1,9 will be maintained and ASA will be administered in dose of 100mg per day with adjustments based on VerifyNow testing. Follow up will last for 12 months after HeartMate 3 implantation. Subsequently, the objectives of the study will be analyzed and evaluated.

Official Title
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A Safety and Feasibility Study of Low-intensity Anticoagulation With HeartMate 3 LVAS: A Single Center Prospective Controlled Study (MAGENTUM 1)

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 an indication data collection for major thrombophilic mutations including anti-phospholipid syndrome and lupus anticoagulant testing prior to low-intensity protocol anticoagulation initiation has been performed patient will be compliant with an anticoagulation management in a judgment of the investigator patient in stable condition with anticipated home discharge Exclusion Criteria: absence of an informed consent presence of additional MCS e.g. ECMO, RVAD in less than 7 days prior to low- intensity protocol anticoagulation initiation known history of major thrombotic event e.g. DVT presence of other than biological valve prosthesis in aortic position left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant hemodynamically significant or symptomatic carotid artery stenosis prior to low-intensity protocol anticoagulation initiation

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reduced Anticoagulation<br>Reduced anticoagulation | Drug: Warfarin<br>* Reduced dosage to obtain lower INR range<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival-free rate of thromboembolic and hemorrhagic events | 12 month survival-free rate of thromboembolic events (i.e. pump thrombosis, disabling stroke MRS>3) and hemorrhagic events (major bleeding, hemorrhagic stroke). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Event rates as assessed per INTERMACS definitions. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduced anti-coagulation, mechanical circulatory support.