Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Survival free of a pump malfunction due to thrombosis or any ischemic stroke
研究概览
简要总结
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.
详细描述
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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Anit-thrombotic monotherapy
Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA).
干预措施: Warfarin (Drug)
结局指标
主要结局
Survival free of a pump malfunction due to thrombosis or any ischemic stroke
时间窗: 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.
次要结局
- Adverse Events(180 days)
研究者
Prof. Ivan Netuka, MD, Ph.D.
Chairman of the Department of Cardiovascular Surgery
Institute for Clinical and Experimental Medicine