Physiological Control for Mechanical Circulatory Devices

NCT ID: NCT04786236

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2021-05-26

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Interventions

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

Software, which sets the device speed according to physiological demand, is activated for the duration of the tests (up to 4 hours). Every patient provides his/her own control, because sequences with active control and with standard pump operation are subsequently performed in randomized order (determined by permutated blocks).

Intervention Type: DEVICE

Other Intervention Names

Automatic Speed Adaptation for Left Ventricular Assist Devices

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich Schima

OTHER

Sponsor Role: lead

Responsible Party

Heinrich Schima

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 35548436 (View on PubMed)

Other Identifiers

REGALVAD

Identifier Type: -

Identifier Source: org_study_id