Clinical evaluation of the Carmat total artificial heart for patients with advanced heart failure
- Conditions
- end stage Heart failure1001928010007593
- Registration Number
- NL-OMON55007
- Lead Sponsor
- CARMAT SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 3
1) Patient age: 18 to 75 years
2) Inotrope dependent or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are
contraindicated (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:
a. 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
b. Treatment-refractory recurrent and sustained ventricular tachycardia or
ventricular fibrillation in the presence of untreatable arrhythmogenic
pathologic substrate
c. 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 up study
requirements
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 or
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) Severe End-organ dysfunction as per any of the following criteria:
a. Total bilirubin > 100 µmol/L (5,8 mg/dl) or cirrhosis evidenced by
ultrasound, CT-scan and positive biopsy
b. 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 (women of childbearing age will have to show
negative pregnancy test)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Survival at 180 days after Carmat TAH implantation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Overall survival<br /><br>- Health status change as measured by EuroQol, EQ-5D-5L and SF36<br /><br>- Functional status change as measured by NYHA and 6MWT<br /><br>- Adverse events incidence and frequency<br /><br>- Time to first discharge and incidence of re-hospitalization</p><br>