Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICEV-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.
Sponsors
Abiomed Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gather clinical event data | 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 | Until study completion, an average of 1 year | Confirmation of usability and ease of use by collection of user data and operational console data |
Countries
Germany
Outcome results
None listed