Status:
TERMINATED
Physiological Control for Mechanical Circulatory Devices
Lead Sponsor:
Heinrich Schima
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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. ...
Detailed Description
Patients complete a set of tests in constant speed setting and repeat the same tests with physiological control algorithms turned on. Order is randomized.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04786236
Start Date
December 14 2020
End Date
May 26 2021
Last Update
January 6 2022
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090