Status:
RECRUITING
Carmat Total Artificial Heart As a Bridge to Transplant in Patients with Advanced Heart Failure
Lead Sponsor:
Carmat SA
Conditions:
Advanced Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 eligib...
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. Clinica...
Eligibility Criteria
Inclusion
- Patient 18 years or older
- Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant
- On inotropes or cardiac Index (CI) \< 2.2 L/min/m2
- On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/HAS)
- Eligible to biventricular Mechanical Circulatory Support according to one of the following category:
- 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
- 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) and by the screening committee (for Cohort 1).
- Patient's affiliation to health care insurance
- Patient has signed the informed consent.
Exclusion
- Absolute contra-indication for heart transplant
- Existence of any ongoing non-temporary mechanical circulatory support
- Existence of any ongoing peripheral mechanical circulatory support such as ECMO, Impella (all types), IABP with a support duration \> 21 days
- Patient intubated and unconscious; or intubated and not awake
- Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
- Coagulopathy defined by platelets \< 100G/l or INR ≥ 1.5 not due to anticoagulant therapy.
- Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent venous thromboembolic events requiring long term curative oral anticoagulation.
- Cerebrovascular accident \< 3 months or symptomatic (Rankin score \>1; Glasgow score \< 14) 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 the following criteria:
- Total bilirubin \> 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound, IRM and positive biopsy
- GFR \< 30ml/min/1.73m2 (with no hemodialysis)
- History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease with FEV1/FVC \<0.7 and FEV1\<50% predicted.
- Recent active blood stream infection confirmed by a positive hemoculture within 48 hours.
- Documented amyloid light-chain (AL amyloidosis).
- Hemodynamically significant peripheral vascular disease assessed by clinical exam.
- Illness, other than heart disease, that would limit survival to less than 2 years.
- 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.).
- Pregnancy or breast feeding (woman in 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.
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04475393
Start Date
December 12 2022
End Date
April 1 2027
Last Update
January 28 2025
Active Locations (10)
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1
Hôpital Louis Pradel
Bron, France, 69500
2
CHU Dijon
Dijon, France, 21000
3
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, 92350
4
Centre Hospitalier Régional Universitaire
Lille, France, 59000