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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03078374

Enrollment

Registered

2017-03-13

Start date

2017-01-11

Completion date

2022-10-31

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Failure

Keywords

Reduced anti-coagulation, mechanical circulatory support.

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.

Interventions

DRUGWarfarin

Reduced dosage to obtain lower INR range

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse Events	12 months	Adverse Event rates as assessed per INTERMACS definitions.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026