Status:
SUSPENDED
Carmat TAH Early Feasibility Study
Lead Sponsor:
Carmat SA
Conditions:
End-stage Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure.
Detailed Description
This is a prospective, multi-center, staged feasibility study designed to assess the initial evidence of safety and performance of the Carmat TAH in the treatment of severe, end-stage heart failure. T...
Eligibility Criteria
Inclusion
- Must be 18 years of age or older at the time of informed consent
- Anatomic compatibility confirmed using 3D imaging (CT-scan).
- Inotrope dependent (with documented attempt to wean) or cardiac Index (CI) \< 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).
- On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/AHA).
- Eligible for biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support:
- Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure: RVEF ≤30%; RVSWI ≤0.25mmHg\*L/m2; TAPSE ≤14mm; RV-to-LV end-diastolic diameter ratio \>0.72; CVP \>15 mmHg; CVP-to-PCWP ratio \>0.63; Tricuspid insufficiency grade 4; PAPi\<2
- 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).
- Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.
- Eligible for cardiac transplantation
Exclusion
- Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
- Presence of any non-temporary mechanical circulatory support
- Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days
- Presence of ECMO with a duration greater than 7 days
- Patient is intubated and unconscious, or intubated and not awake
- Coagulopathy defined by platelets \< 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
- Cerebrovascular accident \< 3 months or symptomatic 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 any of the following criteria:
- Total bilirubin \> 2.5 mg/dl or cirrhosis evidenced by ultrasound, CT-scan and positive biopsy
- eGFR \< 30ml/min/1.73m2 or the need for chronic renal replacement therapy
- History of severe Chronic Obstructive Pulmonary Disease with FEV1/FVC \<0.7, or FEV1\<50% predicted or severe restrictive lung disease.
- Recent blood stream infection (\<7 days).
- Documented amyloid light-chain (AL amyloidosis).
- Hemodynamically significant peripheral vascular disease with documented ankle- brachial pressure index (ABPI) \<0.3.
- Illness, other than heart disease, that would limit survival to less than 2 years.
- Irreversible cognitive dysfunction, psychosocial 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.).
- Current or planned pregnancy or breast feeding (woman of 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 :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04117295
Start Date
July 12 2021
End Date
January 1 2027
Last Update
January 28 2025
Active Locations (4)
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1
University of Louisville Jewish Hospital
Louisville, Kentucky, United States, 40202
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Baylor University Medical Center
Dallas, Texas, United States, 75226
4
VCU Medical Center
Richmond, Virginia, United States, 23298