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Physiological Control for Mechanical Circulatory Devices

NCT04786236 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-01-06

No results posted yet for this study

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

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Heinrich Schima

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-05-26
Completion
2021-05-26

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786236 on ClinicalTrials.gov