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Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure | Clinical Trials | Clareo Health

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

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

NCT04475393•Carmat SAS

View on ClinicalTrials.gov

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.

Detailed 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more 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:
+10 more criteria

Locations (10)

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

Hôpital Laennec

Nantes, France

Groupe Hospitalier Pitié-Salpêtrière,

Paris, France

Hôpital Européen George Pompidou

Paris, France

Hôpital Pontchaillou

Rennes, France

Nouvel Hôpital Civil

Strasbourg, France

Key Dates

Start Date

December 12, 2022

Primary Completion Date

October 24, 2025

Completion Date

April 1, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Heart Failure

Interventions

Carmat Total Artificial Heart

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer

Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients

Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

Hong Kong and Taiwan HM3 PMS

South Of France Cardiac Assist Registry

Screening for Advanced Heart Failure Treatment (SEE-HF)