Heart FailureNCT05759377
V-A ECMO AUTO Mode Registry
An observational study of Heart Failure, run by Abiomed Inc. at 6 sites in Germany.
Trial summary
Abiomed Impella V-A ECMO AUTO Mode - Observational Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- V-A ECMO AUTO Mode algorithm
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 6 sitesGermany
- Study dates
- 11 Oct 2023to 3 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated with concomitant VA ECMO and Impella CP® heart pump (ECpella) due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis).
Who may be able to join
- Patients with ongoing or planned ECpella therapy
Who cannot join
- Age < 18 years
- Treatment with other than VA ECMO setup
- Treatment with Impella CP® heart pump only
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
HDZ NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
Herzzentrum Dresden GmbH
Dresden, Saxony, 01307
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, 20251
UKGM Universtitätsklinikum Marburg
Marburg
Krankenhaus der Barmherzigen Brüder - Herzzentrum Trier
Trier
About this study
Official title: Abiomed Impella V-A ECMO AUTO Mode - Observational Study
Abiomed Impella V-A ECMO AUTO Mode - Observational Study
Read the 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
- Being tested
- V-A ECMO AUTO Mode algorithm
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-A ECMO AUTO Mode algorithmDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until one of the devices is permanently weaned, on average 5 days
Usability assessment
Confirmation of usability and ease of use by collection of user data and operational console data
Measured: Until study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start11 Oct 2023
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Kersten, MD, Principal investigator, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759377
- Sponsor's protocol ID
- 2022-R02
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abiomed Impella V-A ECMO AUTO Mode - Observational Study
- ClinicalTrials.gov ID
- NCT05759377
- Acronym / sponsor ID
- 2022-R02
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with concomitant VA ECMO and Impella CP® heart pump (ECpella) due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis).
Key inclusion criteria (1 listed)
- Patients with ongoing or planned ECpella therapy
Key exclusion criteria (3 listed)
- Age < 18 years
- Treatment with other than VA ECMO setup
- Treatment with Impella CP® heart pump only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-A ECMO AUTO Mode algorithmThe 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. | Device | – |
Primary outcome
Gather clinical event data
Time frame: Until one of the devices is permanently weaned, on average 5 days
Collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm
Usability assessment
Time frame: Until study completion, an average of 1 year
Confirmation of usability and ease of use by collection of user data and operational console data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Kersten, MD principal investigator
Uniklinik RWTH Aachen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abiomed Inc. at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gather clinical event data (time frame: Until one of the devices is permanently weaned, on average 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.