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The HVAD, which is the device to which the control algorithms are applied, was discontinued by the manufacturer.
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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:
Patients complete a set of tests in constant speed setting and repeat the same tests with physiological control algorithms turned on. Order is randomized.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | duration of the testing (up to 4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
The System is contraindicated:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35548436 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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Patients are blinded to their current control mode.
| 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. | Duration of the testing (up to 4 hours) |