V-A ECMO AUTO Mode Registry | Clinical Trial

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinik RWTH Aachen, Aachen, North Rhine-Westphalia, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Mar 8, 2023
Registry last updated: Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed