Safety and Feasibility of Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Single Center Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- survival free rate of thromboembolic events
研究概览
简要总结
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.
详细描述
Patients implanted with the HeartMate 3 LVAS in whom at least 6 months reduced anticoagulation therapy (INR range 1.5-1.9 along with antiplatelet therapy) has been accomplished safely will be screened for participation in the study. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) and anticoagulation with warfarin will be removed. 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 endpoint will be analyzed at 90 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
- Treatment
- 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
- •6 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
排除标准
- •absence of an informed consent
- •presence of any prosthetic valve
- •known history of major thrombotic event e.g. 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
- •any clinical indication for use of long-term warfarin anticoagulation (e.g. known genetic thrombotic mutation, malignancy)
研究组 & 干预措施
Single anti-thrombotic treatment
Single anti-thrombotic treatment
干预措施: Warfarin (Drug)
结局指标
主要结局
survival free rate of thromboembolic events
时间窗: 90 days
Determination of survival free of thromboembolic events (i.e. pump thrombosis or any ischemic stroke) using only a single antithrombotic therapy with Acetylsalicylic Acid.
次要结局
- Adverse Events(90 days)
研究者
Prof. Ivan Netuka, MD, Ph.D.
Chairman of the Department of Cardiovascular Surgery
Institute for Clinical and Experimental Medicine