Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2023-10-11
2025-06-03
Brief Summary
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Detailed Description
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The primary objective is thus the collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm for the Impella pump. This is accompanied by a secondary objective assessing usability, confirming the user friendliness and ease of use by collection of user experience and insights through a questionnaire and data on alarms and manual user interaction with the AIC out of the operational console data.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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V-A ECMO AUTO Mode algorithm
The clinical effects of utilizing the V-A ECMO AUTO Mode in parallel with VA ECMO treatment shall be assessed in different clinical settings. For this, a set of relevant clinical situations and findings ("events") has been defined as trigger points where technical (via AIC) and clinical data shall be collected, linked, and analyzed. This assessment of raw data is important to further develop and adapt the software.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Treatment with other than VA ECMO setup
* Treatment with Impella CP® heart pump only
18 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alexander Kersten, MD
Role: PRINCIPAL_INVESTIGATOR
Uniklinik RWTH Aachen
Locations
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Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
HDZ NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany
Herzzentrum Dresden GmbH
Dresden, Saxony, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, , Germany
UKGM Universtitätsklinikum Marburg
Marburg, , Germany
Krankenhaus der Barmherzigen Brüder - Herzzentrum Trier
Trier, , Germany
Countries
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Other Identifiers
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2022-R02
Identifier Type: -
Identifier Source: org_study_id
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