Aeson TAH System - Post-Market Clinical Follow-up Study
- Conditions
- Heart Failure
- Registration Number
- NCT05474092
- Lead Sponsor
- Carmat SA
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 95
- Patient is intended to receive an Aeson TAH system according to the IFU indications within standard medical practice
- Patient has provided written informed consent using the Ethics Committee approved consent form
Non-inclusion Criteria:
- Vulnerable populations who could not voluntarily consent to participate in the study
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival rate 90 days post-implant Proportion of patients surviving on the originally implanted Aeson device (superiority test \> 64%)
- Secondary Outcome Measures
Name Time Method Frequency and Incidence of Serious Adverse events before transplantation 3, 6, 9, 12, 18 and 24-months post-implant As defined by INTERMACS
Functional status change before transplantation 3, 6, 9, 12, 18 and 24-months post-implant Measured by 6 minutes walking distance in meters
Length of hospital stay and time at home before transplantation 3, 6, 9, 12, 18 and 24-months post-implant Measured with discharge timing, frequency and duration of rehospitalizations; time at home or rehabilitation site
Survival and total support duration before transplantation 6, 12, 18 and 24-months post-implant Survival post-implant
Health status change before transplantation 3, 6, 9, 12, 18 and 24-months post-implant Measured by EuroQol EQ-5D-5L questionnaire, health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (EQ-5D-5L). The responses record five levels of severity (1:no problems; 2:slight problems; 3:moderate problems 4:severe problems; 5:extreme problems) within a particular EQ-5D dimension
Assess the effectiveness of device upgrades Between 3 and 24 months post-implantation, when heart transplant occurred Standard expertise of explanted device
Confirm the safety profile of the device after transplantation 30 days, 3 months, 6 months, 12 months post-transplantation Survival after transplantation
Trial Locations
- Locations (1)
HZ Dresden
🇩🇪Dresden, Germany