V-A ECMO AUTO Mode Registry

Last updated: November 28, 2024
Sponsor: Abiomed Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

V-A ECMO AUTO Mode algorithm

Clinical Study ID

NCT05759377
2022-R02
  • Ages > 18
  • All Genders

Study Summary

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with ongoing or planned ECpella therapy

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • Treatment with other than VA ECMO setup

  • Treatment with Impella CP® heart pump only

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: V-A ECMO AUTO Mode algorithm
Phase:
Study Start date:
October 11, 2023
Estimated Completion Date:
June 01, 2025

Study Description

The overall objective of this study is to collect data during routine Impella usage in an ECpella setting to analyze and assess potential clinical effects, usability, and ease of use of an automated Impella mode to run in conjunction with a VA ECMO system for continued assessment and development of the underlying algorithms in different clinical settings.

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.

Connect with a study center

  • Uniklinik RWTH Aachen

    Aachen, NRW 52074
    Germany

    Active - Recruiting

  • HDZ NRW

    Bad Oeynhausen, NRW 32545
    Germany

    Active - Recruiting

  • Herzzentrum Dresden GmbH

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Universitäres Herz- und Gefäßzentrum Hamburg

    Hamburg, 20251
    Germany

    Active - Recruiting

  • UKGM Universtitätsklinikum Marburg

    Marburg,
    Germany

    Site Not Available

  • Brüderkrankenhaus Trier

    Trier,
    Germany

    Site Not Available

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