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European Clinical Evaluation of the Carmat Total Artificial Heart (ADVANCE HF)

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ClinicalTrials.gov Identifier: NCT02962973
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Carmat SA

Brief Summary:

The purpose of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in patients suffering from advanced heart failure and requiring biventricular support.

Each subject receiving the Carmat TAH is followed to the primary and secondary endpoints at 6 months, with a subsequent follow-up period extending to 2 years post implant.

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


Condition or disease Intervention/treatment Phase
Advanced Heart Failure Device: CARMAT Total Artificial Heart Procedure: surgical procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure
Study Start Date : August 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Patient implanted Device: CARMAT Total Artificial Heart
Procedure: surgical procedure



Primary Outcome Measures :
  1. Survival [ Time Frame: 180 days ]

    The primary objective of the study is survival on a Carmat device at 180 days post-implant or survival to cardiac transplantation if occurring before 180 days post-implant.

    The primary endpoint will be presented as a proportion.



Secondary Outcome Measures :
  1. Evolution of the NHYA classicafication [ Time Frame: 180 days ]
    NYHA classification will be assessed at baseline and 1, 3, 6 months post-implant

  2. Improvement of the 6 Minutes Walk Test [ Time Frame: 180 days ]
    The 6MWT will be assessed at baseline and 1, 3, 6 months post-implant

  3. Improvement in the Quality Of Life assessed with EQ-ED-5L questionnaire [ Time Frame: 180 days ]
    The EQ-5D-5L health index and Visual Analogue Scale (VAS) scores will be assessed at baseline and 1, 3, 6 months post-implant

  4. Improvement in the Quality Of Life assessed with SF36 questionnaire [ Time Frame: 180 days ]
    The SF36 Mental Component Summary and Physical Component Summary scores will be assessed at baseline and 1, 3, 6 months post-implant

  5. Adverse events [ Time Frame: 180 days ]

    Adverse events per INTERMACS definitions, collected during the study course

    • Frequency and incidence of all adverse events
    • Frequency and incidence of pre-defined anticipated adverse events
    • Frequency, incidence and type of device malfunction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age: 18 to 75 years
  2. Inotrope dependent or cardiac Index (CI) < 2.2 L/min/m2 while not on inotropes
  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:

      • RVEF ≤ 30%
      • RVSWI ≤ 0.25 mmHg*L/m2
      • TAPSE ≤ 14mm
      • RV-to-LV end-diastolic diameter ratio > 0.72
      • CVP > 15mmHg
      • CVP-to-PCWP ratio > 0.63
      • 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. Not eligible for transplant or eligible and age 55 year or older with an expected waiting time for heart transplant exceeding 12 months as estimated by physician.
  6. Anatomic compatibility confirmed using 3D imaging (CT-scan)
  7. Patient's affiliation to health care insurance
  8. Signed informed consent obtained

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
  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)

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): NCT02962973


Contacts
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Contact: Elisabeth Vacher +33(0)6 34 92 86 84 clinique@carmatsas.com
Contact: Elisabeth Vacher

Locations
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France
CHRU de Lille - Hôpital cardiologique Recruiting
Lille, France, 59000
Hôpital Louis Pradel Not yet recruiting
Lyon, France, 69000
Hôpital Arnaud De Villeneuve Recruiting
Montpellier, France, 34000
Hôpital Laënnec Recruiting
Nantes, France, 44000
Hôpital de la Pitié Salpêtriere Recruiting
Paris, France, 75013
Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France, 75015
Hôpital Du Haut Leveque Recruiting
Pessac, France, 33600
Hospice Civil de Strasbourg Not yet recruiting
Strasbourg, France, 67000
Hôpital Du Rangueil Recruiting
Toulouse, France, 31000
Sponsors and Collaborators
Carmat SA
Investigators
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Study Director: Piet Jansen, Dr Carmat SA

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Responsible Party: Carmat SA
ClinicalTrials.gov Identifier: NCT02962973     History of Changes
Other Study ID Numbers: CAR2016-01
CIV-FR-16-09-016865 ( Other Identifier: EUDAMED )
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Carmat SA:
Advanced heart failure
Total artificial heart

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases