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Active, not recruitingNCT04475393EFICASUpdated Apr 28, 2026

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

An interventional study of Carmat Total Artificial Heart and Standard therapy for heart failure in Advanced Heart Failure, sponsored by Carmat SAS. Active, not recruiting at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Carmat SAS · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Advanced Heart Failure
03

In context

Lead sponsor

Carmat SAS is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient 18 years or older
  2. Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant
  3. On inotropes or cardiac Index (CI) \< 2.2 L/min/m2
  4. On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/HAS)

  5. Eligible to biventricular Mechanical Circulatory Support according to one of the following category:

    1. Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:

      • 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
    2. Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
    3. Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis / senile or other infiltrative heart disease)
  6. Anatomic compatibility confirmed using 3D imaging (CT-scan) and by the screening committee (for Cohort 1).
  7. Patient's affiliation to health care insurance
  8. Patient has signed the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Absolute contra-indication for heart transplant
  2. Existence of any ongoing non-temporary mechanical circulatory support
  3. Existence of any ongoing peripheral mechanical circulatory support such as ECMO, Impella (all types), IABP with a support duration > 21 days
  4. Patient intubated and unconscious; or intubated and not awake
  5. Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
  6. Coagulopathy defined by platelets \< 100G/l or INR ≥ 1.5 not due to anticoagulant therapy.
  7. Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent venous thromboembolic events requiring long term curative oral anticoagulation.
  8. Cerebrovascular accident \< 3 months or symptomatic (Rankin score >1; Glasgow score \< 14) or a known > 80% carotid stenosis.
  9. Known abdominal or thoracic aortic aneurysm > 5 cm that has not been treated.

  10. Severe end-organ dysfunction as per the following criteria:

    1. Total bilirubin > 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound, IRM and positive biopsy
    2. GFR \< 30ml/min/1.73m2 (with no hemodialysis)
  11. History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease with FEV1/FVC \<0.7 and FEV1\<50% predicted.
  12. Recent active blood stream infection confirmed by a positive hemoculture within 48 hours.
  13. Documented amyloid light-chain (AL amyloidosis).
  14. Hemodynamically significant peripheral vascular disease assessed by clinical exam.
  15. Illness, other than heart disease, that would limit survival to less than 2 years.
  16. 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.).
  17. Pregnancy or breast feeding (woman in childbearing age will have to show negative pregnancy test).
  18. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Carmat TAH (Cohort 1)

    Subjects implanted with Carmat TAH

    Device: Carmat Total Artificial Heart

  • Active comparator
    Standard Therapy (cohort 2)

    Standard Therapy

    Other: Standard therapy for heart failure

Interventions

  • DeviceCarmat Total Artificial Heart

    Heart Replacement Therapy

  • OtherStandard therapy for heart failure

    Other approaches in Bridge to Transplantation

06

What researchers measure

Primary outcomes

  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

    Time frame: 180 days

Secondary outcomes

  1. Overall survival

    Survival after initial TAH implantation; Survival post-transplantation

    Time frame: 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.

    Time frame: 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.

    Time frame: 180 days - 1 and 2 years

  4. Change in functional status

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

    Time frame: 180 days - 1 and 2 years

  5. Adverse Events

    Adverse Event Rates will be captured per the INTERMACS definitions

    Time frame: 180 days - 1 and 2 years

  6. Hospital re-admissions rate

    Rate of unplanned re-admissions to the hospital

    Time frame: 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

    Time frame: 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.

    Time frame: 1 and 2 years

07

Study locations

10 sites
  • Hôpital Louis Pradel
    Bron, 69500, France
  • CHU Dijon
    Dijon, 21000, France
  • Hôpital Marie Lannelongue
    Le Plessis-Robinson, 92350, France
  • Centre Hospitalier Régional Universitaire
    Lille, 59000, France
  • CHRU Montpellier
    Montpellier, 34090, France
  • Hôpital Laennec
    Nantes, 44093, France
  • Groupe Hospitalier Pitié-Salpêtrière,
    Paris, 75013, France
  • Hôpital Européen George Pompidou
    Paris, 75015, France
  • Hôpital Pontchaillou
    Rennes, 35033, France
  • Nouvel Hôpital Civil
    Strasbourg, 67000, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No — European regulation on personal data protection

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04475393
Lead sponsor
Carmat SAS
Responsible party
Sponsor
First posted
Jul 17, 2020
Start date
Dec 12, 2022
Primary completion
Oct 24, 2025
Completion
Apr 2027 (estimated)
Last update
Apr 28, 2026

Study contacts

Frederic C Daoud, MD, PhD
study director · Carmat SAS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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