V-A ECMO AUTO Mode Registry

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05759377
• Lead Sponsor: Abiomed Inc.

Brief Summary

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

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 Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Study Start: 2023-10-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gather clinical event data	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	Until study completion, an average of 1 year	Confirmation of usability and ease of use by collection of user data and operational console data

Trial Locations

Locations (6)

UKGM Universtitätsklinikum Marburg; 🇩🇪 Marburg, Germany

Brüderkrankenhaus Trier; 🇩🇪 Trier, Germany

Uniklinik RWTH Aachen; 🇩🇪 Aachen, NRW, Germany

HDZ NRW; 🇩🇪 Bad Oeynhausen, NRW, Germany

Herzzentrum Dresden GmbH; 🇩🇪 Dresden, Saxony, Germany

Universitäres Herz- und Gefäßzentrum Hamburg; 🇩🇪 Hamburg, Germany