European Clinical Evaluation of the Carmat Total Artificial Heart

  • STATUS
    Recruiting
  • End date
    Dec 26, 2021
  • participants needed
    20
  • sponsor
    Carmat SA
Updated on 26 March 2021
Investigator
Elisabeth Vacher
Primary Contact
Institute for Clinical and Experimental Medicine (1.2 mi away) Contact
+5 other location

Summary

The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support.

Each subject receiving the Carmat TAH will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.

The results of the study will be used to support a CE mark application.

Description

Center selection is based on the following: experience with VAD/TAH implantation and record of good results in this patient population (% of survival), the infrastructure required to perform the clinical investigation (especially the surgical and cardiology teams); site resources and experience to manage the clinical study and the patient population; the adherence to the standards of Good Clinical Practice. A specific focus during the site selection is done on dedicated VAD - nurse team to ensure that:

  • Sites are experienced in the selection of patients whom require a mechanical circulatory support. Social and psychological conditions of the patient and family must be considered to ensure patient and family commitment in the care pathway,
  • Close supervision of patients on the use of the device (when changing batteries) by experienced hospital professionals is guarantee;
  • Extensive hospital training program and regular support for patients and family - relatives are ensured.

Details
Condition Advanced Heart Failure
Treatment surgical procedure, Surgical intervention, CARMAT Total Artificial Heart, CARMAT TAH
Clinical Study IdentifierNCT02962973
SponsorCarmat SA
Last Modified on26 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient age: 18 to 75 years
Inotrope dependent 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 to 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 0.25 mmHgL/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
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's affiliation to health care insurance, if local requirement
Anatomic compatibility confirmed using 3D imaging (CT-scan)
Patient has signed the informed consent and committed to follow study requirements

Exclusion Criteria

Body Mass Index (BMI) < 15 or > 47
Existence of any temporary mechanical circulatory support other than IABP and Impella
Existence of any ongoing non-temporary mechanical circulatory support
History of cardiac or other organ transplant
Patients who have required cardiopulmonary resuscitation for > 30 minutes within 14 days prior to implant
Known intolerance to anticoagulant or antiplatelet therapies
Coagulopathy defined by platelets < 100k/l or INR 1.5 not due to anticoagulant therapy
Cerebro-vascular accident < 3 months or symptomatic or a known > 80% carotid stenosis
Known abdominal or thoracic aortic aneurysm > 5 cm
End-organ dysfunction as per investigator judgment and following but not limited
criteria
Total bilirubin > 100 mol/L (5,8 mg/dl) or cirrhosis evidenced by ultrasound, CT-scan or positive biopsy
GFR < 30ml/min/1.73m2
History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease
Recent blood stream infection (<7 days)
Documented amyloid light-chain (AL amyloidosis)
Hemodynamically significant peripheral vascular disease accompanied by rest pain or extremity ulceration
Illness, other than heart disease, that would limit survival to less than 1 year
Irreversible cognitive dysfunction, psychosocial issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management
Participation in any other clinical investigation that is likely to confound study results or affect the study
Pregnancy or breast feeding (woman in age of childbearing will have to show negative pregnancy test)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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