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

Not Applicable

Recruiting

• Conditions: Advanced Heart Failure

• Registration Number: NCT04475393
• Lead Sponsor: Carmat SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-7-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Patient 18 years or older<br><br> 2. Patient in the waiting list for heart transplant or temporarily contraindicated for<br> heart transplant<br><br> 3. On inotropes or cardiac Index (CI) < 2.2 L/min/m2<br><br> 4. On Optimal Medical Management as judged by the investigator based on current Heart<br> Failure practice guidelines (ESC/HAS)<br><br> 5. Eligible to biventricular Mechanical Circulatory Support according to one of the<br> following category:<br><br> 1. Biventricular failure with at least two of the following hemodynamic/<br> echocardiographic measurements implying right heart failure:<br><br> - RVEF = 30% or FAC < 35%<br><br> - RVSWI = 0.25 mmHg*L/m2<br><br> - TAPSE = 14mm<br><br> - RV-to-LV end-diastolic diameter ratio > 0.72<br><br> - CVP > 15 mmHg or persistence of echographic and/or biological signs of<br> hepatic congestion<br><br> - CVP-to-PCWP ratio > 0.63<br><br> - PAP index <2<br><br> - Tricuspid insufficiency grade 4<br><br> 2. Treatment-refractory recurrent and sustained ventricular tachycardia or<br> ventricular fibrillation in the presence of untreatable arrhythmogenic<br> pathologic substrate.<br><br> 3. Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic<br> cardiomyopathy, cardiac amyloidosis / senile or other infiltrative heart<br> disease)<br><br> 6. Anatomic compatibility confirmed using 3D imaging (CT-scan) and by the screening<br> committee (for Cohort 1).<br><br> 7. Patient's affiliation to health care insurance<br><br> 8. Patient has signed the informed consent.<br><br>Exclusion Criteria:<br><br> 1. Absolute contra-indication for heart transplant<br><br> 2. Existence of any ongoing non-temporary mechanical circulatory support<br><br> 3. Existence of any ongoing peripheral mechanical circulatory support such as ECMO,<br> Impella (all types), IABP with a support duration > 21 days<br><br> 4. Patient intubated and unconscious; or intubated and not awake<br><br> 5. Known intolerance to anticoagulant or antiplatelet therapies or known Heparin<br> Induced Thrombocytopenia.<br><br> 6. Coagulopathy defined by platelets < 100G/l or INR = 1.5 not due to anticoagulant<br> therapy.<br><br> 7. Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent<br> venous thromboembolic events requiring long term curative oral anticoagulation.<br><br> 8. Cerebrovascular accident < 3 months or symptomatic (Rankin score >1; Glasgow score <<br> 14) or a known > 80% carotid stenosis.<br><br> 9. Known abdominal or thoracic aortic aneurysm > 5 cm that has not been treated.<br><br> 10. Severe end-organ dysfunction as per the following criteria:<br><br> 1. Total bilirubin > 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound,<br> IRM and positive biopsy<br><br> 2. GFR < 30ml/min/1.73m2 (with no hemodialysis)<br><br> 11. History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung<br> disease with FEV1/FVC <0.7 and FEV1<50% predicted.<br><br> 12. Recent active blood stream infection confirmed by a positive hemoculture within 48<br> hours.<br><br> 13. Documented amyloid light-chain (AL amyloidosis).<br><br> 14. Hemodynamically significant peripheral vascular disease assessed by clinical exam.<br><br> 15. Illness, other than heart disease, that would limit survival to less than 2 years.<br><br> 16. Irreversible cognitive dysfunction, psycho-cognitive disabilities, psycho-social<br> issues or psychiatric disease, likely to impair compliance with the study protocol<br> and TAH management that in the opinion of the investigator could interfere with the<br> ability to manage the therapy (i.e. non-compliance to heart failure therapy,<br> uncontrolled diabetes, mental health issue, etc.).<br><br> 17. Pregnancy or breast feeding (woman in childbearing age will have to show negative<br> pregnancy test).<br><br> 18. Patient is currently enrolled or has participated in the last 30 days in another<br> therapeutic or interventional clinical study that is likely to confound the study<br> results or affect the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival free of disabling stroke at 180 days post-implant

Secondary Outcome Measures

Name	Time	Method
Overall survival;General Health Status change;Change in functional status measured by the Six Minutes Walk Test;Change in functional status;Adverse Events;Hospital re-admissions rate;Healthcare costs;Quality Adjusted Life Years