V-A ECMO AUTO Mode Registry

NCT05759377 | Completed

• 1 other identifier: 2022-R02
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 6

Brief Summary

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Gather clinical event data

  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

  Confirmation of usability and ease of use by collection of user data and operational console data

  Until study completion, an average of 1 year

Interventions

V-A ECMO AUTO Mode algorithm DEVICE

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

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients with ongoing or planned ECpella therapy

You may not qualify if:

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

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (6)

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

HDZ NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Herzzentrum Dresden GmbH

Dresden, Saxony, 01307, Germany

Location

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, 20251, Germany

Location

UKGM Universtitätsklinikum Marburg

Marburg, Germany

Location

Krankenhaus der Barmherzigen Brüder - Herzzentrum Trier

Trier, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alexander Kersten, MD

  Uniklinik RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 8, 2023
• Study Start: October 11, 2023
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)