A Safety and Feasibility Study of Low-intensity Anticoagulation With HeartMate 3 LVAS: A Single Center Prospective Controlled Study (MAGENTUM 1)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 主要终点
- Survival-free rate of thromboembolic and hemorrhagic events
研究概览
简要总结
The purpose of this study is to obtain single-center safety and feasibility data on patients managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse events associated with the HeartMate 3 LVAS therapy.
详细描述
Patients with implanted HeartMate 3 device will be bridged with heparin until target International Normalized Ratio (INR) of 2,0 - 3,0 will be reached on anticoagulation therapy with Warfarin. Along with Warfarin, Acetylsalicylic Acid (ASA) will be administered in dose of 100mg per day. Enrollment for the study will take place in 1-6 weeks post implant of HeartMate 3. Low-intensity anticoagulation protocol will be started at 6 weeks after implant. Target INR of 1,5-1,9 will be maintained and ASA will be administered in dose of 100mg per day with adjustments based on VerifyNow testing. Follow up will last for 12 months after HeartMate 3 implantation. Subsequently, the objectives of the study will be analyzed and evaluated.
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 an indication
- •data collection for major thrombophilic mutations including anti-phospholipid syndrome and lupus anticoagulant testing prior to low-intensity protocol anticoagulation initiation has been performed
- •patient will be compliant with an anticoagulation management in a judgment of the investigator
- •patient in stable condition with anticipated home discharge
排除标准
- •absence of an informed consent
- •presence of additional MCS e.g. ECMO, RVAD in less than 7 days prior to low- intensity protocol anticoagulation initiation
- •known history of major thrombotic event e.g. DVT
- •presence of other than biological valve prosthesis in aortic position
- •left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant
- •hemodynamically significant or symptomatic carotid artery stenosis prior to low-intensity protocol anticoagulation initiation
研究组 & 干预措施
Reduced Anticoagulation
Reduced anticoagulation
干预措施: Warfarin (Drug)
结局指标
主要结局
Survival-free rate of thromboembolic and hemorrhagic events
时间窗: 12 months
12 month survival-free rate of thromboembolic events (i.e. pump thrombosis, disabling stroke MRS\>3) and hemorrhagic events (major bleeding, hemorrhagic stroke).
次要结局
- Adverse Events(12 months)
研究者
Prof. Ivan Netuka, MD, Ph.D.
Vice Chairman of Cardiac Centre
Institute for Clinical and Experimental Medicine