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

Not Applicable

• Conditions: Heart Failure; Cardiovascular Diseases
• Interventions: Drug: Warfarin

• Registration Number: NCT03078374
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-11
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-01
• Last Update Posted: 2020-08-04
• Primary Completion: 2022-01
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced Anticoagulation	Warfarin	Reduced anticoagulation

Primary Outcome Measures

Name	Time	Method
Survival-free rate of thromboembolic and hemorrhagic events	12 months	12 month survival-free rate of thromboembolic events (i.e. pump thrombosis, disabling stroke MRS\>3) and hemorrhagic events (major bleeding, hemorrhagic stroke).

Secondary Outcome Measures

Name	Time	Method
Adverse Events	12 months	Adverse Event rates as assessed per INTERMACS definitions.