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Advanced Heart FailureEFICASNCT04475393

Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure

A study testing Carmat Total Artificial Heart and Standard therapy for heart failure in people with Advanced Heart Failure, run by Carmat SAS at 10 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Heart Failure
What is being tested?
Carmat Total Artificial Heart and Standard therapy for heart failure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
10 sitesFrance
Study dates
12 Dec 2022to Apr 2027
Phase
Interventional
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

Who may be able to join

  • Patient 18 years or older
  • Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant
  • On inotropes or cardiac Index (CI) < 2.2 L/min/m2
  • On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/HAS)
  • Eligible to biventricular Mechanical Circulatory Support according to one of the following category:
  • Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:
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  • RVEF ≤ 30% or FAC < 35%
  • RVSWI ≤ 0.25 mmHg*L/m2
  • TAPSE ≤ 14mm
  • RV-to-LV end-diastolic diameter ratio > 0.72
  • CVP > 15 mmHg or persistence of echographic and/or biological signs of hepatic congestion
  • CVP-to-PCWP ratio > 0.63
  • PAP index <2
  • Tricuspid insufficiency grade 4
  • Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
  • Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis / senile or other infiltrative heart disease)
  • Anatomic compatibility confirmed using 3D imaging (CT-scan) and by the screening committee (for Cohort 1).
  • Patient's affiliation to health care insurance
  • Patient has signed the informed consent.

Who cannot join

  • Absolute contra-indication for heart transplant
  • Existence of any ongoing non-temporary mechanical circulatory support
  • Existence of any ongoing peripheral mechanical circulatory support such as ECMO, Impella (all types), IABP with a support duration > 21 days
  • Patient intubated and unconscious; or intubated and not awake
  • Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
  • Coagulopathy defined by platelets < 100G/l or INR ≥ 1.5 not due to anticoagulant therapy.
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  • Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent venous thromboembolic events requiring long term curative oral anticoagulation.
  • Cerebrovascular accident < 3 months or symptomatic (Rankin score >1; Glasgow score < 14) or a known > 80% carotid stenosis.
  • Known abdominal or thoracic aortic aneurysm > 5 cm that has not been treated.
  • Severe end-organ dysfunction as per the following criteria:
  • Total bilirubin > 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound, IRM and positive biopsy
  • GFR < 30ml/min/1.73m2 (with no hemodialysis)
  • History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease with FEV1/FVC <0.7 and FEV1<50% predicted.
  • Recent active blood stream infection confirmed by a positive hemoculture within 48 hours.
  • Documented amyloid light-chain (AL amyloidosis).
  • Hemodynamically significant peripheral vascular disease assessed by clinical exam.
  • Illness, other than heart disease, that would limit survival to less than 2 years.
  • Irreversible cognitive dysfunction, psycho-cognitive disabilities, psycho-social issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management that in the opinion of the investigator could interfere with the ability to manage the therapy (i.e. non-compliance to heart failure therapy, uncontrolled diabetes, mental health issue, etc.).
  • Pregnancy or breast feeding (woman in childbearing age will have to show negative pregnancy test).
  • Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound the study results or affect the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Hôpital Louis Pradel

    Bron, 69500

  • CHU Dijon

    Dijon, 21000

  • Hôpital Marie Lannelongue

    Le Plessis-Robinson, 92350

  • Centre Hospitalier Régional Universitaire

    Lille, 59000

  • CHRU Montpellier

    Montpellier, 34090

  • Hôpital Laennec

    Nantes, 44093

  • Groupe Hospitalier Pitié-Salpêtrière,

    Paris, 75013

  • Hôpital Européen George Pompidou

    Paris, 75015

  • Hôpital Pontchaillou

    Rennes, 35033

  • Nouvel Hôpital Civil

    Strasbourg, 67000

Other trials in France

About this study

Official title: Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Clinical Utility and Cost, as a Bridge to Transplantation

The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.

Read the detailed description

A selection committee (composed of minimum two experts in the field of cardiovascular surgery/cardiology and of PIs) assess the subject eligibility based on clinical and anatomic criteria. Clinically eligible patients will be distributed into two cohorts depending on their anatomic compatibility with the device:

  • cohort 1: patients that are anatomically compatible will receive the Carmat TAH ;
  • cohort 2: patients that are not anatomically compatible will receive standard therapy

The efficacy and safety of the Carmat TAH will be assessed in cohort 1 and compared to a level of efficacy defined by the published data on the commercially available TAH; and adjusted for INTERMACS patient profile.

The clinical utility and the costs of Carmat TAH will be assessed by comparing the cohort of subject receiving the Carmat TAH to the cohort of patients treated by standard therapy

Being tested
Carmat Total Artificial Heart, Standard therapy for heart failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carmat Total Artificial HeartDevice

    Heart Replacement Therapy

  • Standard therapy for heart failureOther

    Other approaches in Bridge to Transplantation

Study groups in NCT04475393
Study groupRoleWhat they receive
Carmat TAH (Cohort 1)ExperimentalSubjects implanted with Carmat TAH
Receives: Device: Carmat Total Artificial Heart
Standard Therapy (cohort 2)Active comparatorStandard Therapy
Receives: Other: Standard therapy for heart failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival free of disabling stroke and free of reoperation for device malfunction at 180 days post-implant

    Success is defined as survival free of disabling stroke (Modified Rankin score >3) and free of device malfunction leading to a reoperation for device replacement or urgent transplantation, or electively transplanted within 180 days after Carmat TAH implantation

    Measured: 180 days

Secondary outcomes (8)

  1. Overall survival

    Survival after initial TAH implantation; Survival post-transplantation

    Measured: 180 days - 1 year - 2 years

  2. General Health Status change

    Measured with the 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: 180 days - 1 and 2 years

  3. Change in functional status measured by the Six Minutes Walk Test

    The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

    Measured: 180 days - 1 and 2 years

  4. Change in functional status

    New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)

    Measured: 180 days - 1 and 2 years

  5. Adverse Events

    Adverse Event Rates will be captured per the INTERMACS definitions

    Measured: 180 days - 1 and 2 years

  6. Hospital re-admissions rate

    Rate of unplanned re-admissions to the hospital

    Measured: 180 days - 1 and 2 years

  7. Healthcare costs

    The healthcare resources used to treat the patient during the two-year period, including those related to selection, those related to waiting for transplantation (whatever the therapeutic strategy), to transplantation, post-transplant management and any adverse event

    Measured: 1 and 2 years

  8. Quality Adjusted Life Years

    The Quality Adjusted Life Years, evaluated during the two-year period, values the health outcomes in a single measure by combining both quality of life (evaluated by EuroQol EQ-5D-5L) and lenght of life.

    Measured: 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2020
  2. Study start12 Dec 2022
  3. Primary completion24 Oct 2025
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04475393
Sponsor's protocol ID
CAR2019-FR
Acronym
EFICAS
Status last verified
Apr 2026
First submitted
14 Jul 2020
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: European regulation on personal data protection

Publications

  • Kirklin JK, Xie R, Cowger J, de By TMMH, Nakatani T, Schueler S, Taylor R, Lannon J, Mohacsi P, Gummert J, Goldstein D, Caliskan K, Hannan MM. Second annual report from the ISHLT Mechanically Assisted Circulatory Support Registry. J Heart Lung Transplant. 2018 Jun;37(6):685-691. doi: 10.1016/j.healun.2018.01.1294. Epub 2018 Jan 31.

    PubMed 29550146

  • Arabia FA, Cantor RS, Koehl DA, Kasirajan V, Gregoric I, Moriguchi JD, Esmailian F, Ramzy D, Chung JS, Czer LS, Kobashigawa JA, Smith RG, Kirklin JK. Interagency registry for mechanically assisted circulatory support report on the total artificial heart. J Heart Lung Transplant. 2018 Nov;37(11):1304-1312. doi: 10.1016/j.healun.2018.04.004. Epub 2018 Apr 26.

    PubMed 29802083

Questions about this trial

What is this clinical trial studying?

A study testing Carmat Total Artificial Heart and Standard therapy for heart failure in people with Advanced Heart Failure, run by Carmat SAS at 10 sites in France.

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 19 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival free of disabling stroke and free of reoperation for device malfunction at 180 days post-implant (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04475393, which also lists 2 linked publications.

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 Apr 2026.

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