Physiological Control for Mechanical Circulatory Devices (REGALVAD)

Heinrich Schima

Status

Terminated

Conditions

Heart Failure

Treatments

Device: Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device

Study type

Interventional

Funder types

Other

Identifiers

NCT04786236

REGALVAD

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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: