NCT04786236终止不适用
Pilot Study for the Evaluation of Control Algorithms for Mechanical Circulatory Support Devices Based on Physiological Demand
Heinrich Schima1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Device Feasibility
研究概览
简要总结
Aim of this clinical study is to compare our newly developed control algorithms for mechanical circulatory support devices based on physiological demand with the standard manual LVAD speed operation. Specifically it shall be demonstrated that:
- Suction is properly detected by the pre-trained pump flow estimation algorithm
- Suction events (due to changes in physiological demand) can be reduced by control algorithms compared to continuous speed
- If suction is encountered, it can be detected and cleared
- The pump reacts adequately to changes in patient demand due to physical activity
- Physicians pump setpoints (of requested speed for a certain heartrate) can be achieved safely.
详细描述
Patients complete a set of tests in constant speed setting and repeat the same tests with physiological control algorithms turned on. Order is randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
盲法说明
Patients are blinded to their current control mode.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a Medtronic HVAD system implanted at the Medical University of Vienna, Division of Cardiac Surgery, which are able and willing to understand and sign the informed consent form, and which do not meet any
排除标准
- •will be included.
- •Exclusion Criteria:
- •Inability to provide informed consent
- •Patients with known intraventricular or aortic root thrombus formation confirmed by transthoracic ultrasound diagnostic
- •Known pathology of the coagulatory system
- •Supra or sub-therapeutic anticoagulation (aPTT or INR)
- •Suspected or confirmed pump thrombus (based on lab parameters, abnormal high pump power consumption or acoustic spectral analysis)
- •History of ischemic or hemorrhagic stroke (<2 months)
- •Hypertension at rest (mean arterial pressure > 120mmHg)
- •Cerebrovascular or musculoskeletal disease preventing the performance of daily life activities or exercise training
- •Severe arrhythmia (e.g. long QT syndrome), ventricular fibrillation or required defibrillation - excluding the LVAD implantation - in the previous 2 months
- •All contraindications applicable to the HVAS are applicable to this study.
- •The System is contraindicated:
- •In patients with a body surface area (BSA) less than 1.2 m²
- •In patients who cannot tolerate anticoagulation therapy
- •During pregnancy
结局指标
主要结局
Device Feasibility
时间窗: duration of the testing (up to 4 hours)
Feasibility of the Control algorithm to safely adapt pump speed within provided limits, quantified by the number of necessary switchovers to manual mode
次要结局
- Quantification of overpumping by number of suction events / minute during lying, standing and sitting and comparison with constant speed mode.(Duration of the testing (up to 4 hours))
- Quantification of overpumping by number of suction events / minute due to change of position from lying sitting and sitting to standing compared to the situation in constant speed mode.(Duration of the testing (up to 4 hours))
研究者
Heinrich Schima
Professor
Medical University of Vienna
研究点 (1)
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