Anti-thrombotic Monotherapy With the HeartMate 3 LVAS

Heart Failure Clinical Trial

Official title:

Safety and Feasibility of Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Single Center Prospective Controlled Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03704220
• Other study ID #: Version1.0
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: December 2021

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 a single-center safety and feasibility data on patients managed with a single anti-thrombotic therapy and the incidence of thrombotic adverse events associated with HeartMate 3 LVAS therapy.

Description:

Patients implanted with the HeartMate 3 LVAS in whom at least 6 months reduced anticoagulation therapy (INR range 1.5-1.9 along with antiplatelet therapy) has been accomplished safely will be screened for participation in the study. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) and anticoagulation with warfarin will be removed. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoint will be analyzed at 90 days after initiation of the single antiplatelet therapy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy

• 6 months or more on reduced anti-coagulation regimen (target INR 1.5-1.9) free of thromboembolic and thrombotic complications

• evidence of forward flow across the aortic valve (with aortic valve opening of at least 1:2 per cardiac cycle) at baseline echocardiography (ECHO) or after the speed optimization without a significant progression of heart failure based on a biomarker and complex clinical assessment follow-up

Exclusion Criteria:

• absence of an informed consent

• presence of any prosthetic valve

• known history of major thrombotic event e.g. DVT

• known history of stroke

• left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant

• evidence of any intracardiac thrombus

• any clinical indication for use of long-term warfarin anticoagulation (e.g. known genetic thrombotic mutation, malignancy)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure

Intervention

Drug:
• Warfarin
Removal of anticoagulation with warfarin

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague	Prague 4

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Abbott

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11. — View Citation

Netuka I, Ivák P, Tucanová Z, Gregor S, Szárszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival free rate of thromboembolic events	Determination of survival free of thromboembolic events (i.e. pump thrombosis or any ischemic stroke) using only a single antithrombotic therapy with Acetylsalicylic Acid.	90 days
Secondary	Adverse Events	Adverse events rates per INTERMACS definitions.	90 days

External Links

•   Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study
•   Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure