V-A ECMO AUTO Mode Registry

Status Recruiting

Clinical Trial Summary

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Clinical Trial 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 Design

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT05759377
Study type	Observational
Source	Abiomed Inc.
Contact	Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
Phone	+49 241 8860
Email	agoetzenich@abiomed.com
Status	Recruiting
Phase
Start date	October 11, 2023
Completion date	September 1, 2024

View Details

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