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

Institute for Clinical and Experimental Medicine

Status

Unknown

Conditions

Cardiovascular Diseases

Heart Failure

Treatments

Drug: Warfarin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03078374

Version 2.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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