Observational study on the use of Impella with VA ECMO
Official title: Abiomed Impella V-A ECMO AUTO Mode - Observational Study
Run by Abiomed Inc. · NCT05759377 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see how well the automated Impella device works with VA ECMO therapy in patients and how easy it is for doctors to use.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Abiomed Inc. Industry-sponsored |
| Locations | 6 sites (Aachen, NRW and 5 other locations) |
| Trial ID | NCT05759377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients currently undergoing or scheduled for ECpella therapy.
✕Probably not a fit
Patients under 18 years old or those receiving treatment with a different ECMO setup or only the Impella CP® heart pump may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect data on the routine use of the Impella V-A ECMO AUTO Mode in patients undergoing ECpella therapy. It focuses on analyzing clinical effects, usability, and ease of use of the automated Impella mode in conjunction with a VA ECMO system. The study will gather clinical events to create a database for post-hoc analysis of the V-A ECMO AUTO Mode algorithm, while also assessing user experience through questionnaires and operational data. The goal is to enhance the understanding and development of the underlying algorithms in various clinical settings.
Why it matters
Potential benefit: If successful, this study could improve the management of heart failure patients receiving ECMO therapy by optimizing the use of the Impella device.
How similar studies have gone: While this approach is observational and builds on existing technologies, similar studies have shown promise in optimizing ECMO and Impella usage, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Uniklinik RWTH Aachen
Aachen, Nrw, Germany Recruiting -
Hdz Nrw
Bad Oeynhausen, Nrw, Germany Recruiting -
Herzzentrum Dresden GmbH
Dresden, Saxony, Germany Recruiting -
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany Recruiting -
UKGM Universtitätsklinikum Marburg
Marburg, Germany Not yet recruiting -
Brüderkrankenhaus Trier
Trier, Germany Not yet recruiting
Study contacts
- Principal investigator: Alexander Kersten, MD — Uniklinik RWTH Aachen
- Study coordinator: Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
- Email: agoetzenich@abiomed.com
- Phone: +49 241 8860
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.