Anti-thrombotic Monotherapy With the HeartMate 3 LVAS

• ClinicalTrials.gov Identifier: NCT03704220
• Recruitment Status: Enrolling by invitation
• First Posted: October 12, 2018
• Last Update Posted: August 4, 2020
• Sponsor: Institute for Clinical and Experimental Medicine
• Collaborator: Abbott
• Information provided by (Responsible Party): Prof. Ivan Netuka, MD, Ph.D., Institute for Clinical and Experimental Medicine

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Cardiovascular Diseases	Drug: Warfarin	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Feasibility of Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Single Center Prospective Controlled Study
• Actual Study Start Date: August 16, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Single anti-thrombotic treatment; Single anti-thrombotic treatment	Drug: Warfarin; Removal of anticoagulation with warfarin

Outcome Measures

Primary Outcome Measures :

1. survival free rate of thromboembolic events [ Time Frame: 90 days ]
   Determination of survival free of thromboembolic events (i.e. pump thrombosis or any ischemic stroke) using only a single antithrombotic therapy with Acetylsalicylic Acid.

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: 90 days ]
   Adverse events rates per INTERMACS definitions.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Czechia

Institute for Clinical and Experimental Medicine

Prague, Prague 4, Czechia, 14021

Sponsors and Collaborators

Institute for Clinical and Experimental Medicine

Abbott

More Information

Additional Information:

Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure 

Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study 

Publications:

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.

Netuka I, Ivák P, Tučanová 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.

• Responsible Party: Prof. Ivan Netuka, MD, Ph.D., Chairman of the Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine
• ClinicalTrials.gov Identifier: NCT03704220
• Other Study ID Numbers: Version1.0
• First Posted: October 12, 2018
• Last Update Posted: August 4, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Ivan Netuka, MD, Ph.D., Institute for Clinical and Experimental Medicine:

Single anti-thrombotic therapy; Mechanical circulatory support

Additional relevant MeSH terms:

Cardiovascular Diseases; Warfarin; Anticoagulants