Physiological Control for Mechanical Circulatory Devices (NCT04786236) | Clinical Trial Compass
TerminatedNot Applicable
Physiological Control for Mechanical Circulatory Devices
Stopped: The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.
Austria7 participantsStarted 2020-12-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 exclusion criteria 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device Feasibility
Timeframe: duration of the testing (up to 4 hours)