Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)

NCT03781258 | Unknown

• 1 other identifier: Version 1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective controlled study is to obtain a multi-center safety and feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.

Conditions

Heart Failure; Cardiovascular Diseases

Keywords

Mechanical circulatory support; Anti-thrombotic monotherapy

Outcome Measures

Primary Outcomes (1)

• Survival free of a pump malfunction due to thrombosis or any ischemic stroke

  To determine survival free of a pump malfunction due to thrombosis or any ischemic stroke at 90-days (primary safety end point) and at 180-days (primary efficacy end point) in patients implanted with HeartMate 3 LVAS after transition to a single antithrombotic with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy.

  180 days

Secondary Outcomes (1)

• Adverse Events

  180 days

Study Arms (1)

Anit-thrombotic monotherapy

OTHER

Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA).

Drug: Warfarin

Interventions

Warfarin DRUG

Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.

Anit-thrombotic monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy
• a minimum of 6 months since HeartMate3 LVAS implantation free of thromboembolic events and pump malfunction
• 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 speed reduction as long as no evidence of progression of heart failure is noted, based on a combination of biomarkers and clinical assessment follow-up (see Appendix III); Clinical assessment will include review of the biomarkers, invasive or non-invasive hemodynamics (as available or indicated) and clinical physical examination

You may not qualify if:

• absence of an informed consent
• presence of any prosthetic valve or central aortic valve repair (e.g. Park's stitch)
• presence of any other ancillary circulatory assist device system
• known history of major thrombotic event e.g. deep vein thrombosis (DVT)
• known history of stroke
• evidence of any intracardiac thrombus evidenced by transoesophageal echocardiography
• any other clinical indication for a use of long-term anticoagulation using a vitamin K antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation mandating the therapy, malignancy)

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead
• Abbott: collaborator

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Prague 4, 14021, Czechia

Location

Related 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.

  PMID: 29526139 BACKGROUND

• Netuka I, Ivak P, Tucanova Z, Gregor S, Szarszoi 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.

  PMID: 29655662 BACKGROUND

Related Links

• 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 Minimal AnticoaGulation EvaluatioN To aUgment heMocompatibility (MAGENTUM) 1 study

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of Cardiovascular Surgery

Model Details: Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent and anticoagulation with warfarin will be withdrawn. 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 and 180 days after initiation of the single antiplatelet therapy.

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 19, 2018
• Study Start: November 23, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 4, 2020

Record last verified: 2020-08

Locations

CZ (1)