V-A ECMO AUTO Mode Registry

Heart Failure Clinical Trial

Official title:

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759377
• Other study ID #: 2022-R02
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Abiomed Inc.
• Contact: Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
• Phone: +49 241 8860
• Email: agoetzenich[@]abiomed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gather clinical event data	Collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm	Until one of the devices is permanently weaned, on average 5 days
Primary	Usability assessment	Confirmation of usability and ease of use by collection of user data and operational console data	Until study completion, an average of 1 year