V-A ECMO AUTO Mode Registry

Abiomed

Status: Completed

Conditions: Heart Failure

Treatments: Device: V-A ECMO AUTO Mode algorithm

Study type: Observational

Funder types: Industry

Identifiers

NCT05759377

2022-R02

Details and patient eligibility

About

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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