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REGALVAD: Physiological Control for Mechanical Circulatory Devices

Sponsor
Heinrich Schima (Other)
Overall Status
Terminated
CT.gov ID
NCT04786236
Collaborator
(none)
7
Enrollment
1
Location
5.4
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
Patients are blinded to their current control mode.
Primary Purpose:
Device Feasibility
Official Title:
Pilot Study for the Evaluation of Control Algorithms for Mechanical Circulatory Support Devices Based on Physiological Demand
Actual Study Start Date :
Dec 14, 2020
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Outcome Measures

Primary Outcome Measures

  1. Device Feasibility [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

Secondary Outcome Measures

  1. 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)]

    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.

  2. 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)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Heinrich Schima

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heinrich Schima, Professor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04786236
Other Study ID Numbers:
  • REGALVAD
First Posted:
Mar 8, 2021
Last Update Posted:
Jan 6, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Heinrich Schima, Professor, Medical University of Vienna
LVAD
Physiological Control
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jan 6, 2022