Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04475393
Other study ID # CAR2019-FR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 12, 2022
Est. completion date April 2027

Study information

Verified date January 2024
Source Carmat SA
Contact Soumia Aoualli
Phone +33 63 826 5953
Email clinique@carmatsas.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

A selection committee (composed of two independent 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


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date April 2027
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient 18 years or older 2. Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant 3. Inotrope dependent* or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology). * Inotrope dependence needs to be confirmed by failed weaning or justified in medical records. 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% - 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 - 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: 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 < 40ml/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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Carmat Total Artificial Heart
Heart Replacement Therapy

Locations

Country Name City State
France Hôpital Louis Pradel Bron
France CHU Dijon Dijon
France Hôpital Marie Lannelongue Le Plessis-Robinson
France Centre Hospitalier Régional Universitaire Lille
France CHRU Montpellier Montpellier
France Groupe Hospitalier Pitié-Salpêtrière, Paris
France Hôpital Européen George Pompidou Paris
France Hôpital Pontchaillou Rennes
France Nouvel Hôpital Civil Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Carmat SA

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival free of disabling stroke at 180 days post-implant Success is defined as survival free of disabling stroke (Modified Rankin score >3) at 180 days after Carmat TAH
implantation or transplanted if before 180 days.
180 days
Secondary Overall survival Survival post-implant; Survival post-transplantation (Kaplan-Meier) 180 days - 1 year
Secondary 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. 180 days - 1 and 2 years
Secondary 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. 180 days - 1 and 2 years
Secondary Change in functional status New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV) 180 days - 1 and 2 years
Secondary Adverse Events Adverse Event Rates will be captured per the INTERMACS definitions 180 days - 1 and 2 years
Secondary Hospital re-admissions rate Rate of unplanned re-admissions to the hospital 180 days - 1 and 2 years
Secondary 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 180 days - 1 and 2 years
Secondary 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. 180 days - 1 and 2 years
See also
  Status Clinical Trial Phase
Suspended NCT02962973 - European Clinical Evaluation of the Carmat Total Artificial Heart N/A
Recruiting NCT04915924 - Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea N/A
Completed NCT01626404 - Screening for Advanced Heart Failure Treatment (SEE-HF)
Withdrawn NCT00572286 - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study N/A
Completed NCT00690157 - Registry of Patients Referred for Heart Transplantation N/A
Active, not recruiting NCT03874312 - Ultrasound-assessed Internal Jugular Vein Distensibility in Advanced Chronic Heart Failure (US-IJVD in CHF)
Enrolling by invitation NCT00988806 - Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure Phase 4
Recruiting NCT05284955 - Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B) Phase 4
Completed NCT01643551 - Neuron Specific Enolase in Ventricular Assist Device Recipients N/A
Terminated NCT04703855 - Hong Kong and Taiwan HM3 PMS N/A
Suspended NCT04851236 - Pilot Study of Massage Therapy to Improve Self Efficacy in Patients With Left-ventricular Device Early Phase 1
Recruiting NCT03526627 - Advanced Care Management in Patients With Advanced Heart Failure
Recruiting NCT06228209 - Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer N/A
Active, not recruiting NCT06259045 - Cardiac Cachexia in Advanced Heart Failure
Recruiting NCT05271214 - Conservative Management of Left Ventricular Assist Device Candidates
Recruiting NCT03919136 - Wrist Worn Blood Pressure Measurement
Recruiting NCT03911349 - Wrist Worn Blood Pressure Measurement N/A
Completed NCT01210573 - Prospective Observation of Exercise Parameters in Advanced Heart Failure N/A
Recruiting NCT04423562 - PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices