Physiological Control for Mechanical Circulatory Devices

NCT04786236 | Terminated DMC

• 1 other identifier: REGALVAD
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

LVAD; Physiological Control

Outcome Measures

Primary Outcomes (1)

• Device Feasibility

  Feasibility of the Control algorithm to safely adapt pump speed within provided limits, quantified by the number of necessary switchovers to manual mode

  duration of the testing (up to 4 hours)

Secondary Outcomes (2)

• Quantification of overpumping by number of suction events / minute during lying, standing and sitting and comparison with constant speed mode.

  Duration of the testing (up to 4 hours)

• 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.

  Duration of the testing (up to 4 hours)

Interventions

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

Also known as: Automatic Speed Adaptation for Left Ventricular Assist Devices

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich Schima: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 35548436 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded to their current control mode.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 8, 2021
• Study Start: December 14, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)