Clinical trial NCT04786236: Physiological Control for Mechanical Circulatory Devices
Official title: Pilot Study for the Evaluation of Control Algorithms for Mechanical Circulatory Support Devices Based on Physiological Demand
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: LVAD
Physiological Control
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients undergo testings in constant speed mode and physiologically controlled mode on the same day. the sequence is randomized. The number of patients was chosen due to the fact (experience in clinical care of the patients) the anatomical situation, the pump position due to surgical implant and the patient condition can vary to a high extent.
Primary purpose: DEVICE_FEASIBILITY

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. 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.

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 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

Primary outcomes:
measure: Device Feasibility
timeFrame: duration of the testing (up to 4 hours)
Secondary outcomes:
measure: Quantification of overpumping by number of suction events / minute during lying, standing and sitting and comparison with constant speed mode.
timeFrame: Duration of the testing (up to 4 hours)
measure: 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.
timeFrame: Duration of the testing (up to 4 hours)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Maw M, Schloglhofer T, Marko C, Aigner P, Gross C, Widhalm G, Schaefer AK, Schima M, Wittmann F, Wiedemann D, Moscato F, Kudlik D, Stadler R, Zimpfer D, Schima H. A Sensorless Modular Multiobjective Control Algorithm for Left Ventricular Assist Devices: A Clinical Pilot Study. Front Cardiovasc Med. 2022 Apr 25;9:888269. doi: 10.3389/fcvm.2022.888269. eCollection 2022.