Heart FailureREGALVADNCT04786236
Physiological Control for Mechanical Circulatory Devices
A study of Heart Failure, run by Heinrich Schima at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteAustria
- Study dates
- 14 Dec 2020to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device
- Keywords
- LVAD, Physiological Control
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist DeviceDevice
Also called Automatic Speed Adaptation for Left Ventricular Assist Devices
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 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.
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.
Measured: Duration of the testing (up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start14 Dec 2020
- Primary completion26 May 2021
- Study completion26 May 2021
Why it stopped: The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich Schima
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heinrich Schima, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786236
- Sponsor's protocol ID
- REGALVAD
- Acronym
- REGALVAD
- Status last verified
- Dec 2021
- First submitted
- 2 Feb 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35548436
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of Control Algorithms for Mechanical Circulatory Support Devices Based on Physiological Demand
- ClinicalTrials.gov ID
- NCT04786236
- Acronym / sponsor ID
- REGALVAD / REGALVAD
- Conditions
- Heart Failure
- Keywords
- LVAD, Physiological Control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Heinrich SchimaUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- 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.
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist DeviceAlso: Automatic Speed Adaptation for Left Ventricular Assist DevicesSoftware, 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). | Device | – |
Primary outcome
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
2 secondary outcomes
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)
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)
Results and safety
The study was stopped early (reason given: The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 35548436Maw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure, run by Heinrich Schima at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Feasibility (time frame: duration of the testing (up to 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04786236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.