Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-28 @ 11:47 AM
Study NCT ID:
NCT05474092
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aeson TAH System - Post-Market Clinical Follow-up Study
Sponsor:
Carmat SA
Organization:
Study Overview
Official Title:
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: