European Clinical Evaluation of the Carmat Total Artificial Heart (ADVANCEHF)

This is an interventional treatment trial for Advanced Heart Failure focused on measuring Advanced heart failure, Total artificial heart Read More

Inclusion Criteria:

1. Patient age: 18 to 75 years
2. Inotrope dependent or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).
3. On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/AHA)

4. Eligible to biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support:

   1. Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:

      1. RVEF ≤ 30%
      2. RVSWI ≤ 0.25 mmHg*L/m2
      3. TAPSE ≤ 14mm
      4. RV-to-LV end-diastolic diameter ratio > 0.72
      5. CVP > 15 mmHg
      6. CVP-to-PCWP ratio > 0.63
      7. 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)
5. Anatomic compatibility confirmed using 3D imaging (CT-scan)
6. Patient's affiliation to health care insurance, if local requirement
7. Patient has signed the informed consent and committed to follow study requirements

Exclusion Criteria:

1. Body Mass Index (BMI) < 15 or > 47
2. Existence of any ongoing non-temporary mechanical circulatory support
3. Existence of any temporary mechanical circulatory support other than IABP and Impella
4. History of cardiac or other organ transplant
5. Patients who have required cardiopulmonary resuscitation for > 30 minutes within 14 days prior to implant
6. Known intolerance to anticoagulant or antiplatelet therapies
7. Coagulopathy defined by platelets < 100k/μl or INR ≥ 1.5 not due to anticoagulant therapy
8. Cerebro-vascular accident < 3 months or symptomatic or a known > 80% carotid stenosis
9. Known abdominal or thoracic aortic aneurysm > 5 cm

10. End-organ dysfunction as per investigator judgment and following but not limited criteria:

    1. Total bilirubin > 100 μmol/L (5,8 mg/dl) or cirrhosis evidenced by ultrasound, CT-scan or positive biopsy
    2. GFR < 30ml/min/1.73m2
11. History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease
12. Recent blood stream infection (<7 days)
13. Documented amyloid light-chain (AL amyloidosis)
14. Hemodynamically significant peripheral vascular disease accompanied by rest pain or extremity ulceration
15. Illness, other than heart disease, that would limit survival to less than 1 year
16. Irreversible cognitive dysfunction, psychosocial issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management
17. Participation in any other clinical investigation that is likely to confound study results or affect the study
18. Pregnancy or breast feeding (woman in age of childbearing will have to show negative pregnancy test)