NCT05759377

V-A ECMO AUTO Mode Registry

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	V-A ECMO AUTO Mode algorithm	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.

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-06-03
• Completion: 2025-06-03
• First posted: 2023-03-08
• Last updated: 2025-07-03

Locations

6 sites across 1 country: Germany