Aeson TAH System - Post-Market Clinical Follow-up Study

Study Overview
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Brief Summary
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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
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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: 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. Assess the effectiveness of device upgrades 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.

Official Title
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Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Aeson Total Artificial Heart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aeson Total Artificial Heart|Heart Replacement Therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Proportion of patients surviving on the originally implanted Aeson device (superiority test > 64%) | 90 days post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival and total support duration before transplantation | Survival post-implant | 6, 12, 18 and 24-months post-implant | 
| Health status change before transplantation | 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 | 3, 6, 9, 12, 18 and 24-months post-implant | 
| Functional status change before transplantation | Measured by 6 minutes walking distance in meters | 3, 6, 9, 12, 18 and 24-months post-implant | 
| Length of hospital stay and time at home before transplantation | Measured with discharge timing, frequency and duration of rehospitalizations; time at home or rehabilitation site | 3, 6, 9, 12, 18 and 24-months post-implant | 
| Frequency and Incidence of Serious Adverse events before transplantation | As defined by INTERMACS | 3, 6, 9, 12, 18 and 24-months post-implant | 
| Assess the effectiveness of device upgrades | Standard expertise of explanted device | Between 3 and 24 months post-implantation, when heart transplant occurred | 
| Confirm the safety profile of the device after transplantation | Survival after transplantation | 30 days, 3 months, 6 months, 12 months post-transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Heart Failure, Total Artificial Heart, Bridge to Transplant