Trials / Recruiting
RecruitingNCT05474092
Aeson TAH System - Post-Market Clinical Follow-up Study
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 95 (estimated)
- Sponsor
- Carmat SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the Aeson TAH system when used in routine care by surgeons.
Detailed description
The Primary objective/endpoint is survival rate on the originally implanted Aeson device at 90 days post-implant (H1 \> 64%). The second objectives/endpoints are: 1. Confirm the performance and safety profile of the device for patients implanted with the Aeson TAH system until being transplanted: * Survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation; * Health status change as measured by NYHA classification, 6MWT and Quality of Life Questionnaire (EQ-5D-5L); * Renal and hepatic function as measured by biological parameters; * Hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events; * Frequency and Incidence of Serious Adverse events. 2. Assess the effectiveness of device upgrades 3. Confirm the safety profile of the device for patients after being transplanted. * Survival at 30 days, 6 months, and 12 months post-transplant * Frequency and Incidence of Serious Adverse Event of special interest as graft reject, neurological events, major bleeding.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aeson Total Artificial Heart | Heart Replacement Therapy |
Timeline
- Start date
- 2021-11-23
- Primary completion
- 2028-05-01
- Completion
- 2030-05-01
- First posted
- 2022-07-26
- Last updated
- 2026-01-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05474092. Inclusion in this directory is not an endorsement.