NCT03704220

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

3.3 years

First QC Date

October 10, 2018

Last Update Submit

August 1, 2020

Conditions

Heart FailureCardiovascular Diseases

Keywords

Single anti-thrombotic therapyMechanical circulatory support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse Events

    90 days

Study Arms (1)

Single anti-thrombotic treatment

OTHER

Single anti-thrombotic treatment

Drug: Warfarin

Interventions

WarfarinDRUG

Removal of anticoagulation with warfarin

Single anti-thrombotic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

You may not qualify if:

  • absence of an informed consent
  • presence of any prosthetic valve
  • known history of major thrombotic event e.g. DVT
  • known history of stroke
  • evidence of any intracardiac thrombus
  • any clinical indication for use of long-term warfarin anticoagulation (e.g. known genetic thrombotic mutation, malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 29526139BACKGROUND

  • 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: 29655662BACKGROUND

Related Links

MeSH Terms

Conditions

Heart FailureCardiovascular Diseases

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 12, 2018

Study Start

August 16, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations

CZ(1)