Heart Failure
Conditions
Keywords
Advanced Heart Failure, Total Artificial Heart, Bridge to Transplant
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.
Interventions
DEVICEAeson Total Artificial Heart
Heart Replacement Therapy
Sponsors
Carmat SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 90 days post-implant | Proportion of patients surviving on the originally implanted Aeson device (superiority test \> 64%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Frequency and Incidence of Serious Adverse events before transplantation | 3, 6, 9, 12, 18 and 24-months post-implant | As defined by INTERMACS |
| 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 |
Countries
Germany
Contacts
CONTACTElisabeth Vacher
CONTACTPiet Jansen
Outcome results
None listed