Overview

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

Status:
Enrolling by invitation
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborator:
Abbott
Treatments:
Warfarin
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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 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)