Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)
- Registration Number
- NCT03781258
- Lead Sponsor
- Institute for Clinical and Experimental Medicine
- 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, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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 endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anit-thrombotic monotherapy Warfarin Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA).
- Primary Outcome Measures
Name Time Method Survival free of a pump malfunction due to thrombosis or any ischemic stroke 180 days 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.
- Secondary Outcome Measures
Name Time Method Adverse Events 180 days Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions.
Trial Locations
- Locations (1)
Institute for Clinical and Experimental Medicine
🇨🇿Prague, Prague 4, Czechia