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Advanced Heart FailureADVANCEHFNCT02962973

European Clinical Evaluation of the Carmat Total Artificial Heart

A study testing CARMAT TAH and Surgical intervention in people with Advanced Heart Failure, run by Carmat SAS at 2 sites in 2 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Heart Failure
What is being tested?
CARMAT TAH and Surgical intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
Sep 2016to Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient age: 18 to 75 years
  • Inotrope dependent or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).
  • On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/AHA)
  • Eligible to biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support:
  • Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:
  • RVEF ≤ 30%
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  • RVSWI ≤ 0.25 mmHg*L/m2
  • TAPSE ≤ 14mm
  • RV-to-LV end-diastolic diameter ratio > 0.72
  • CVP > 15 mmHg
  • CVP-to-PCWP ratio > 0.63
  • 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)
  • Patient's affiliation to health care insurance, if local requirement
  • Patient has signed the informed consent and committed to follow study requirements

Who cannot join

  • Body Mass Index (BMI) < 15 or > 47
  • Existence of any ongoing non-temporary mechanical circulatory support
  • Existence of any temporary mechanical circulatory support other than IABP and Impella
  • History of cardiac or other organ transplant
  • Patients who have required cardiopulmonary resuscitation for > 30 minutes within 14 days prior to implant
  • Known intolerance to anticoagulant or antiplatelet therapies
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  • Coagulopathy defined by platelets < 100k/μl or INR ≥ 1.5 not due to anticoagulant therapy
  • Cerebro-vascular accident < 3 months or symptomatic or a known > 80% carotid stenosis
  • Known abdominal or thoracic aortic aneurysm > 5 cm
  • End-organ dysfunction as per investigator judgment and following but not limited criteria:
  • Total bilirubin > 100 μmol/L (5,8 mg/dl) or cirrhosis evidenced by ultrasound, CT-scan or positive biopsy
  • GFR < 30ml/min/1.73m2
  • History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease
  • Recent blood stream infection (<7 days)
  • Documented amyloid light-chain (AL amyloidosis)
  • Hemodynamically significant peripheral vascular disease accompanied by rest pain or extremity ulceration
  • Illness, other than heart disease, that would limit survival to less than 1 year
  • Irreversible cognitive dysfunction, psychosocial issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management
  • Participation in any other clinical investigation that is likely to confound study results or affect the study
  • Pregnancy or breast feeding (woman in age of childbearing will have to show negative pregnancy test)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Kazakhstan1 site

  • "National Research Cardiac Surgery Center"

    Astana, 010000

Other trials in Kazakhstan

Netherlands1 site

  • UMC Utrecht

    Utrecht, 3508GA

Other trials in Netherlands

About this study

Official title: Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure

The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support.

Each subject receiving the Carmat TAH will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.

The results of the study will be used to support a CE mark application.

Read the detailed description

Center selection is based on the following: experience with VAD/TAH implantation and record of good results in this patient population (% of survival), the infrastructure required to perform the clinical investigation (especially the surgical and cardiology teams); site resources and experience to manage the clinical study and the patient population; the adherence to the standards of Good Clinical Practice. A specific focus during the site selection is done on dedicated VAD - nurse team to ensure that:

  • Sites are experienced in the selection of patients whom require a mechanical circulatory support. Social and psychological conditions of the patient and family must be considered to ensure patient and family commitment in the care pathway,
  • Close supervision of patients on the use of the device (when changing batteries) by experienced hospital professionals is guarantee;
  • Extensive hospital training program and regular support for patients and family - relatives are ensured.
Being tested
CARMAT TAH, Surgical intervention
Keywords
Advanced heart failure, Total artificial heart

What participants receive

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

  • CARMAT TAHDevice

  • Surgical interventionProcedure or surgery

Study groups in NCT02962973
Study groupRoleWhat they receive
Carmat TAHExperimentalThe surgical intervention takes place through a midsternotomy utilizing cardiopulmonary bypass. The device is then connected via a percutaneous driveline to an external controller and batteries and takes over the circulation.
Receives: Device: CARMAT TAH; Procedure: Surgical intervention

What is being measured

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

  1. Proportion of participants with survival at 180 days

    Success is defined as survival at 180 days after Carmat TAH implantation or transplanted if before 180 days.

    Measured: 180 days

Secondary outcomes (7)

  1. Overall survival

    Patient follow-up

    Measured: 180 days

  2. General health status change (1)

    Measured with the EuroQol EQ-5D questionnaire, a descriptive system of health-related quality of life states 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

  3. General health status change (2)

    Change as measured by the SF-36 questionnaire, consisting of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

    Measured: 180 days

  4. Functional status change

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

    Measured: 180 days

  5. 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

  6. Adverse events

    Adverse Event Rates will be captured per the INTERMACS definitions

    Measured: 180 days

  7. hospital readmission rate

    Rate of unplanned readmissions to the hospital

    • Frequency and incidence of all adverse events
    • Frequency and incidence of pre-defined anticipated adverse events
    • Frequency, incidence and type of device malfunction

    Measured: 180 days

Timeline

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

  1. First posted15 Nov 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2025 (estimated)
  4. Study completionJul 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02962973
Sponsor's protocol ID
CAR2016-01
Other IDs
CIV-FR-16-09-016865
Acronym
ADVANCEHF
Status last verified
Feb 2025
First submitted
8 Nov 2016
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Netuka I, Pya Y, Bekbossynova M, Ivak P, Konarik M, Gustafsson F, Smadja DM, Jansen P, Latremouille C. Initial bridge to transplant experience with a bioprosthetic autoregulated artificial heart. J Heart Lung Transplant. 2020 Dec;39(12):1491-1493. doi: 10.1016/j.healun.2020.07.004. Epub 2020 Jul 14. No abstract available.

    PubMed 32758387

  • Bizouarn P, Roussel JC, Trochu JN, Perles JC, Latremouille C. Effects of pre-load variations on hemodynamic parameters with a pulsatile autoregulated artificial heart during the early post-operative period. J Heart Lung Transplant. 2018 Jan;37(1):161-163. doi: 10.1016/j.healun.2017.06.018. Epub 2017 Jul 8. No abstract available.

    PubMed 28736110

Questions about this trial

What is this clinical trial studying?

A study testing CARMAT TAH and Surgical intervention in people with Advanced Heart Failure, run by Carmat SAS at 2 sites in 2 countries.

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 17 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: paused, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kazakhstan, Netherlands. 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?

Results are not available in the source record.

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?

Proportion of participants with survival at 180 days (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 NCT02962973, 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 14 Feb 2025.

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