V-A ECMO AUTO Mode Registry

July 2, 2025 updated by: Abiomed Inc.

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • Universitäres Herz- und Gefäßzentrum Hamburg
      • Marburg, Germany
        • UKGM Universtitätsklinikum Marburg
      • Trier, Germany
        • Krankenhaus der Barmherzigen Brüder - Herzzentrum Trier
    • NRW
      • Aachen, NRW, Germany, 52074
        • Uniklinik RWTH Aachen
      • Bad Oeynhausen, NRW, Germany, 32545
        • HDZ NRW
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Herzzentrum Dresden GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients treated with concomitant VA ECMO and Impella CP® heart pump (ECpella) due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis).

Description

Inclusion Criteria:

  • Patients with ongoing or planned ECpella therapy

Exclusion Criteria:

  • Age < 18 years
  • Treatment with other than VA ECMO setup
  • Treatment with Impella CP® heart pump only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gather clinical event data
Time Frame: Until one of the devices is permanently weaned, on average 5 days
Collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm
Until one of the devices is permanently weaned, on average 5 days
Usability assessment
Time Frame: Until study completion, an average of 1 year
Confirmation of usability and ease of use by collection of user data and operational console data
Until study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Investigators

  • Principal Investigator: Alexander Kersten, MD, Uniklinik RWTH Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Actual)

June 3, 2025

Study Completion (Actual)

June 3, 2025

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-R02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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