Physiological Control for Mechanical Circulatory Devices (REGALVAD)

December 15, 2021 updated by: Heinrich Schima

Pilot Study for the Evaluation of Control Algorithms for Mechanical Circulatory Support Devices Based on Physiological Demand

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Feasibility
Time Frame: duration of the testing (up to 4 hours)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of overpumping by number of suction events / minute during lying, standing and sitting and comparison with constant speed mode.
Time Frame: Duration of the testing (up to 4 hours)
Overpumping leads to occlusion of the pump inflow by the ventricular septum and sudden temporary decrease of flow. The number of such events can be counted by analysis of the flow pattern in the pump. The automatic control should lead to a reduction of such events per minute compared to the condition in constant speed.
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.
Time Frame: Duration of the testing (up to 4 hours)
Due to decreased venous return at changes of orthostasis the number of suctions increases in constant speed mode. The control should lead to a reduction of suction events due to intermittent reduction of pump speed. The quantification shall be done by comparing the number of suction events/minute immedeately after such changes in controlled and constant speed mode.
Duration of the testing (up to 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich Schima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Actual)

May 26, 2021

Study Completion (Actual)

May 26, 2021

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGALVAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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