Heart FailureNCT05474092
Aeson TAH System - Post-Market Clinical Follow-up Study
An observational study of Heart Failure, run by Carmat SAS at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aeson Total Artificial Heart
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteGermany
- Study dates
- 23 Nov 2021to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients intended to receive Aeson TAH system as per commercial use
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
HZ Dresden
Dresden, 01307
Manuel Wilbring, +49 351 450 25141, Manuel.Wilbring@herzzentrum-dresden.com
About this study
Official title: Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
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.
Read the 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:
- 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.
- Conditions
- Heart Failure
- Being tested
- Aeson Total Artificial Heart
- Keywords
- Advanced Heart Failure, Total Artificial Heart, Bridge to Transplant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aeson Total Artificial HeartDevice
Heart Replacement Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Proportion of patients surviving on the originally implanted Aeson device (superiority test > 64%)
Measured: 90 days post-implant
Secondary outcomes (7)
Survival and total support duration before transplantation
Survival post-implant
Measured: 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
Measured: 3, 6, 9, 12, 18 and 24-months post-implant
Functional status change before transplantation
Measured by 6 minutes walking distance in meters
Measured: 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
Measured: 3, 6, 9, 12, 18 and 24-months post-implant
Frequency and Incidence of Serious Adverse events before transplantation
As defined by INTERMACS
Measured: 3, 6, 9, 12, 18 and 24-months post-implant
Assess the effectiveness of device upgrades
Standard expertise of explanted device
Measured: Between 3 and 24 months post-implantation, when heart transplant occurred
Confirm the safety profile of the device after transplantation
Survival after transplantation
Measured: 30 days, 3 months, 6 months, 12 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start23 Nov 2021
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmat SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474092
- Sponsor's protocol ID
- CAR2021-PM
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
- ClinicalTrials.gov ID
- NCT05474092
- Acronym / sponsor ID
- CAR2021-PM
- Conditions
- Heart Failure
- Keywords
- Advanced Heart Failure, Total Artificial Heart, Bridge to Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Carmat SASIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients intended to receive Aeson TAH system as per commercial use
Key inclusion criteria (4 listed)
- 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
- Vulnerable populations who could not voluntarily consent to participate in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aeson Total Artificial HeartHeart Replacement Therapy | Device | – |
Primary outcome
Survival rate
Time frame: 90 days post-implant
Proportion of patients surviving on the originally implanted Aeson device (superiority test > 64%)
7 secondary outcomes
Survival and total support duration before transplantation
Time frame: 6, 12, 18 and 24-months post-implant
Health status change before transplantation
Time frame: 3, 6, 9, 12, 18 and 24-months post-implant
Functional status change before transplantation
Time frame: 3, 6, 9, 12, 18 and 24-months post-implant
Length of hospital stay and time at home before transplantation
Time frame: 3, 6, 9, 12, 18 and 24-months post-implant
Frequency and Incidence of Serious Adverse events before transplantation
Time frame: 3, 6, 9, 12, 18 and 24-months post-implant
Assess the effectiveness of device upgrades
Time frame: Between 3 and 24 months post-implantation, when heart transplant occurred
Confirm the safety profile of the device after transplantation
Time frame: 30 days, 3 months, 6 months, 12 months post-transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Carmat SAS at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Vacher (+33 6 34 92 86 84, Elisabeth.Vacher@carmatsas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 90 days post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.