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Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure (EFICAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475393
Recruitment Status : Not yet recruiting
First Posted : July 17, 2020
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Carmat SA

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Heart Failure Device: Carmat Total Artificial Heart Not Applicable

Detailed Description:

A selection committee (composed of two independent experts in the field of cardiovascular surgery/cardiology and of PIs) assess the subject eligibility based on clinical and anatomic criteria. Clinically eligible patients will be distributed into two cohorts depending on their anatomic compatibility with the device:

  • cohort 1: patients that are anatomically compatible will receive the Carmat TAH ;
  • cohort 2: patients that are not anatomically compatible will receive standard therapy

The efficacy and safety of the Carmat TAH will be assessed in cohort 1 and compared to a level of efficacy defined by the published data on the commercially available TAH; and adjusted for INTERMACS patient profile.

The clinical utility and the costs of Carmat TAH will be assessed by comparing the cohort of subject receiving the Carmat TAH to the cohort of patients treated by standard therapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Carmat TAH
Subjects implanted with Carmat TAH
Device: Carmat Total Artificial Heart
Heart Replacement Therapy




Primary Outcome Measures :
  1. Survival free of disabling stroke at 180 days post-implant [ Time Frame: 180 days ]

    Success is defined as survival free of disabling stroke (Modified Rankin score >3) at 180 days after Carmat TAH

    implantation or transplanted if before 180 days.



Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 180 days - 1 year ]
    Survival post-implant; Survival post-transplantation (Kaplan-Meier)

  2. General Health Status change [ Time Frame: 180 days - 1 and 2 years ]
    Measured with the EuroQol EQ-5D-5L questionnaire, health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (EQ-5D-5L). The responses record five levels of severity (1:no problems; 2:slight problems; 3:moderate problems 4:severe problems; 5:extreme problems) within a particular EQ-5D dimension.

  3. Change in functional status measured by the Six Minutes Walk Test [ Time Frame: 180 days - 1 and 2 years ]
    The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  4. Change in functional status [ Time Frame: 180 days - 1 and 2 years ]
    New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)

  5. Adverse Events [ Time Frame: 180 days - 1 and 2 years ]
    Adverse Event Rates will be captured per the INTERMACS definitions

  6. Hospital re-admissions rate [ Time Frame: 180 days - 1 and 2 years ]
    Rate of unplanned re-admissions to the hospital

  7. Healthcare costs [ Time Frame: 180 days - 1 and 2 years ]
    The healthcare resources used to treat the patient during the two-year period, including those related to selection, those related to waiting for transplantation (whatever the therapeutic strategy), to transplantation, post-transplant management and any adverse event

  8. Quality Adjusted Life Years [ Time Frame: 180 days - 1 and 2 years ]
    The Quality Adjusted Life Years, evaluated during the two-year period, values the health outcomes in a single measure by combining both quality of life (evaluated by EuroQol EQ-5D-5L) and lenght of life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient 18 years or older
  2. Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant
  3. Inotrope dependent* or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).

    * Inotrope dependence needs to be confirmed by failed weaning or justified in medical records.

  4. On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/HAS)
  5. Eligible to biventricular Mechanical Circulatory Support according to one of the following category:

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

      • RVEF ≤ 30%
      • RVSWI ≤ 0.25 mmHg*L/m2
      • TAPSE ≤ 14mm
      • RV-to-LV end-diastolic diameter ratio > 0.72
      • CVP > 15 mmHg
      • CVP-to-PCWP ratio > 0.63
      • PAP index <2
      • 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)
  6. Anatomic compatibility confirmed using 3D imaging (CT-scan) and by the screening committee
  7. Patient's affiliation to health care insurance
  8. Patient has signed the informed consent.

Exclusion Criteria:

  1. Absolute contra-indication for heart transplant
  2. Existence of any ongoing non-temporary mechanical circulatory support
  3. Existence of any ongoing peripheral mechanical circulatory support such as ECMO, Impella (all types), IABP with a support duration > 21 days
  4. Patient intubated and unconscious; or intubated and not awake
  5. Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
  6. Coagulopathy defined by platelets < 100G/l or INR ≥ 1.5 not due to anticoagulant therapy.
  7. Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent venous thromboembolic events requiring long term curative oral anticoagulation.
  8. Cerebrovascular accident < 3 months or symptomatic (Rankin score >1; Glasgow score < 14) or a known > 80% carotid stenosis.
  9. Known abdominal or thoracic aortic aneurysm > 5 cm that has not been treated.
  10. Severe end-organ dysfunction as per the following criteria:

    1. Total bilirubin > 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound, IRM and positive biopsy
    2. GFR < 40ml/min/1.73m2 (with no hemodialysis)
  11. History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease with FEV1/FVC <0.7, or FEV1<50% predicted.
  12. Recent active blood stream infection confirmed by a positive hemoculture within 48 hours.
  13. Documented amyloid light-chain (AL amyloidosis).
  14. Hemodynamically significant peripheral vascular disease assessed by clinical exam.
  15. Illness, other than heart disease, that would limit survival to less than 2 years.
  16. Irreversible cognitive dysfunction, psycho-cognitive disabilities, psycho-social 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.).
  17. Pregnancy or breast feeding (woman in childbearing age will have to show negative pregnancy test).
  18. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475393


Contacts
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Contact: Jean-Christophe Perles +33 1 39 45 64 50 clinique@carmatsas.com
Contact: Elisabeth Vacher clinique@carmatsas.com

Locations
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France
Hôpital Louis Pradel,
Bron, France, 69500
Contact: Jean-François OBADIA, MD         
Centre Hospitalier Régional Universitaire
Lille, France, 59000
Contact: André Vincentelli, MD         
Groupe Hospitalier Pitié-Salpêtrière,
Paris, France, 75013
Contact: Pascal Leprince, MD         
Hôpital Pontchaillou
Rennes, France, 35033
Contact: Erwan FLECHER, MD         
Hôpital de Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Carmat SA
Investigators
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Study Director: Piet Jansen, MD Carmat SA
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Responsible Party: Carmat SA
ClinicalTrials.gov Identifier: NCT04475393    
Other Study ID Numbers: CAR2019-FR
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases