Status:
UNKNOWN
Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborating Sponsors:
Abbott
Conditions:
Heart Failure
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
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, pat...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03781258
Start Date
November 23 2018
End Date
December 31 2021
Last Update
August 4 2020
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine
Prague, Prague 4, Czechia, 14021