Observational study on the use of Impella with VA ECMO
Abiomed Impella V-A ECMO AUTO Mode - Observational Study
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abiomed Inc. Industry-sponsored |
| Locations | 6 sites (Aachen, NRW and 5 other locations) |
| Trial ID | NCT05759377 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients currently undergoing or scheduled for ECpella therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aachen, NRW and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.