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

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Collaborator: Abbott
• Treatments: Warfarin

Criteria

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