End-stage Heart FailureNCT04117295
Carmat TAH Early Feasibility Study
A study testing Carmat Total Artificial Heart in people with End-stage Heart Failure, run by Carmat SAS at 4 sites in United States.
Trial summary
Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Heart Failure
- What is being tested?
- Carmat Total Artificial Heart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jul 2021to Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older at the time of informed consent
- Anatomic compatibility confirmed using 3D imaging (CT-scan).
- Inotrope dependent (with documented attempt to wean) 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 for 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%; RVSWI ≤0.25mmHg*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; PAPi<2
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- 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).
- Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.
- Eligible for cardiac transplantation
Who cannot join
- Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
- Presence of any non-temporary mechanical circulatory support
- Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days
- Presence of ECMO with a duration greater than 7 days
- Patient is intubated and unconscious, or intubated and not awake
- Coagulopathy defined by platelets < 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
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- Cerebrovascular accident < 3 months or symptomatic 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 any of the following criteria:
- Total bilirubin > 2.5 mg/dl or cirrhosis evidenced by ultrasound, CT-scan and positive biopsy
- eGFR < 30ml/min/1.73m2 or the need for chronic renal replacement therapy
- History of severe Chronic Obstructive Pulmonary Disease with FEV1/FVC <0.7, or FEV1<50% predicted or severe restrictive lung disease.
- Recent blood stream infection (<7 days).
- Documented amyloid light-chain (AL amyloidosis).
- Hemodynamically significant peripheral vascular disease with documented ankle- brachial pressure index (ABPI) <0.3.
- Illness, other than heart disease, that would limit survival to less than 2 years.
- Irreversible cognitive dysfunction, psychosocial 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.).
- Current or planned pregnancy or breast feeding (woman of 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
4 sites in 1 country.
United States4 sites
Baylor University Medical Center
Dallas, Texas, 75226
Duke University Medical Center
Durham, North Carolina, 27710
University of Louisville Jewish Hospital
Louisville, Kentucky, 40202
VCU Medical Center
Richmond, Virginia, 23298
About this study
Official title: Carmat Total Artificial Heart Early Feasibility Study
Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure.
Read the detailed description
This is a prospective, multi-center, staged feasibility study designed to assess the initial evidence of safety and performance of the Carmat TAH in the treatment of severe, end-stage heart failure. This study will include up to 7 centers in the US. The study population will include up to 10 transplant-eligible patients enrolled and implanted with the Carmat TAH.
Data collection will be recorded prior to implantation of the device and for six months following implant, then long term at 9, 12, 18 and 24 months while the patient remains on the device. Adverse events, as defined by INTERMACS, while on device support will be collected throughout the study until study closure and will be adjudicated by an independent Clinical Event Committee.
Progress reports of the clinical outcomes will be reviewed by the DSMB after implantation of each patient and every three months thereafter while any patient is supported with the device. A progress report will be sent to FDA for review after three subjects have been implanted and followed for 60 days.
The primary objective of the study is survival on an original Carmat device at 180 days post-implant or survival to cardiac transplantation if occurring before 180 days post-implant.
- Conditions
- End-stage Heart Failure
- Being tested
- Carmat Total Artificial Heart
- Keywords
- Heart Replacement Therapy, Total Artificial Heart, Biventricular 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects implanted with the Carmat TAH Receives: Device: Carmat Total Artificial Heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Proportion of patients surviving on the Carmat TAH
Measured: 180 days
Secondary outcomes (7)
Survival without Permanent Neurologic Deficit
Proportion of patients surviving post implant without a permanent disabling stroke (Modified Rankin Scale >3)
Measured: 180 days
Post transplant survival
Proportion of patients surviving 30 days post-transplant
Measured: 30 days
Change in functional status
New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)
Measured: 180 days
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
Generic health status change
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 with the Kansas City Cardiomyopathy Questionnaire, a self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: 180 days
Adverse Events
Adverse Event Rates will be captured per the INTERMACS definitions
Measured: 180 days
Hospital readmission rate
Rate of unplanned readmissions to the hospital
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start12 Jul 2021
- Primary completionApr 2026 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Occurrence of a quality issue affecting some of its prostheses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT04117295
- Sponsor's protocol ID
- CAR2019-US
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2019
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Dual SA, Cowger J, Roche E, Nayak A. The Future of Durable Mechanical Circulatory Support: Emerging Technological Innovations and Considerations to Enable Evolution of the Field. J Card Fail. 2024 Apr;30(4):596-609. doi: 10.1016/j.cardfail.2024.01.011. Epub 2024 Feb 29.
PubMed 38431185
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carmat Total Artificial Heart Early Feasibility Study
- ClinicalTrials.gov ID
- NCT04117295
- Acronym / sponsor ID
- CAR2019-US
- Conditions
- End-stage Heart Failure
- Keywords
- Heart Replacement Therapy, Total Artificial Heart, Biventricular Heart Failure
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Occurrence of a quality issue affecting some of its prostheses
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Carmat SASIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Oct 2019 (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.
Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure.
Detailed description
This is a prospective, multi-center, staged feasibility study designed to assess the initial evidence of safety and performance of the Carmat TAH in the treatment of severe, end-stage heart failure. This study will include up to 7 centers in the US. The study population will include up to 10 transplant-eligible patients enrolled and implanted with the Carmat TAH.
Data collection will be recorded prior to implantation of the device and for six months following implant, then long term at 9, 12, 18 and 24 months while the patient remains on the device. Adverse events, as defined by INTERMACS, while on device support will be collected throughout the study until study closure and will be adjudicated by an independent Clinical Event Committee.
Progress reports of the clinical outcomes will be reviewed by the DSMB after implantation of each patient and every three months thereafter while any patient is supported with the device. A progress report will be sent to FDA for review after three subjects have been implanted and followed for 60 days.
The primary objective of the study is survival on an original Carmat device at 180 days post-implant or survival to cardiac transplantation if occurring before 180 days post-implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Carmat Total Artificial HeartSubjects implanted with the Carmat TAH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be 18 years of age or older at the time of informed consent
- Anatomic compatibility confirmed using 3D imaging (CT-scan).
- Inotrope dependent (with documented attempt to wean) 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 for biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support:
Key exclusion criteria (19 listed)
- Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
- Presence of any non-temporary mechanical circulatory support
- Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days
- Presence of ECMO with a duration greater than 7 days
- Patient is intubated and unconscious, or intubated and not awake
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 |
|---|---|---|
| Carmat Total Artificial HeartHeart replacement therapy | Device | Treatment |
Primary outcome
Survival
Time frame: 180 days
Proportion of patients surviving on the Carmat TAH
7 secondary outcomes
Survival without Permanent Neurologic Deficit
Time frame: 180 days
Post transplant survival
Time frame: 30 days
Change in functional status
Time frame: 180 days
Change in functional status measured by the Six Minutes Walk Test
Time frame: 180 days
Generic health status change
Time frame: 180 days
Adverse Events
Time frame: 180 days
Hospital readmission rate
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 38431185Dual SA, Cowger J, Roche E, Nayak A. The Future of Durable Mechanical Circulatory Support: Emerging Technological Innovations and Considerations to Enable Evolution of the Field. J Card Fail. 2024 Apr;30(4):596-609. doi: 10.1016/j.cardfail.2024.01.011. Epub 2024 Feb 29.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carmat Total Artificial Heart in people with End-stage Heart Failure, run by Carmat SAS at 4 sites in United States.
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 10 inclusion and 19 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Survival (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 NCT04117295, which also lists 1 linked publication.
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 2025.