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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03078374
• Other study ID #: Version 2.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: October 2022

Study information

• Verified date: August 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: October 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure

Intervention

Drug:
• Warfarin
Reduced dosage to obtain lower INR range

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Abbott

References & Publications (3)

Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16. — View Citation

Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinová I, Ivák P, Marecek F, Bílková J, Malíková I, Jancová M, Malý J, Sood P, Sundareswaran KS, Connors JM, Mehra MR. Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure. J Heart Lung Transplant. 2016 Jul;35(7):860-7. doi: 10.1016/j.healun.2016.05.019. Epub 2016 May 31. — View Citation

Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival-free rate of thromboembolic and hemorrhagic events	12 month survival-free rate of thromboembolic events (i.e. pump thrombosis, disabling stroke MRS>3) and hemorrhagic events (major bleeding, hemorrhagic stroke).	12 months
Secondary	Adverse Events	Adverse Event rates as assessed per INTERMACS definitions.	12 months

External Links

•   A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.
•   Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure.
•   Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study.