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

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

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.

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.

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