Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure (NCT04475393) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure
France104 participantsStarted 2022-12-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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)
Exclusion criteria
✕. 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
What they're measuring
1
Survival free of disabling stroke and free of reoperation for device malfunction at 180 days post-implant
✕. 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.