Back to resultsPhysiological Control for Mechanical Circulatory Devices (REGALVAD)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device
Sponsored by
About this trial
This is an interventional device feasibility trial for Heart Failure focused on measuring LVAD, Physiological Control
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04786236
Brief Title
Physiological Control for Mechanical Circulatory Devices
Acronym
REGALVAD
Official Title
Pilot Study for the Evaluation of Control Algorithms for Mechanical Circulatory Support Devices Based on Physiological Demand
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heinrich Schima
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
LVAD, Physiological Control
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
Patients are blinded to their current control mode.
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device
Other Intervention Name(s)
Automatic Speed Adaptation for Left Ventricular Assist Devices
Intervention Description
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).
Primary Outcome Measure Information:
Title
Device Feasibility
Description
Feasibility of the Control algorithm to safely adapt pump speed within provided limits, quantified by the number of necessary switchovers to manual mode
Time Frame
duration of the testing (up to 4 hours)
Secondary Outcome Measure Information:
Title
Quantification of overpumping by number of suction events / minute during lying, standing and sitting and comparison with constant speed mode.
Description
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.
Time Frame
Duration of the testing (up to 4 hours)
Title
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.
Description
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.
Time Frame
Duration of the testing (up to 4 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35548436
Citation
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.
Results Reference
derived
Learn more about this trial
Physiological Control for Mechanical Circulatory Devices
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