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European Clinical Evaluation of the Carmat Total Artificial Heart (ADVANCEHF)

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: NCT02962973
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Carmat SA

Brief 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.


Condition or disease Intervention/treatment Phase
Advanced Heart Failure Device: CARMAT TAH Procedure: Surgical intervention Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Carmat TAH
The surgical intervention takes place through a midsternotomy utilizing cardiopulmonary bypass. The device is then connected via a percutaneous driveline to an external controller and batteries and takes over the circulation.
Device: CARMAT TAH
Procedure: Surgical intervention



Primary Outcome Measures :
  1. Proportion of participants with survival at 180 days [ Time Frame: 180 days ]
    Success is defined as survival at 180 days after Carmat TAH implantation or transplanted if before 180 days.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 180 days ]
    Patient follow-up

  2. General health status change (1) [ Time Frame: 180 days ]
    Measured with the EuroQol EQ-5D questionnaire, a descriptive system of health-related quality of life states 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. General health status change (2) [ Time Frame: 180 days ]
    Change as measured by the SF-36 questionnaire, consisting of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  4. Functional status change [ Time Frame: 180 days ]
    New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)

  5. Change in functional status measured by the Six Minutes Walk Test [ Time Frame: 180 days ]
    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.

  6. Adverse events [ Time Frame: 180 days ]
    Adverse Event Rates will be captured per the INTERMACS definitions

  7. hospital readmission rate [ Time Frame: 180 days ]

    Rate of unplanned readmissions to the hospital

    • 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

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 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 if inotropes are contra-indicated (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:

    1. 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
    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. 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 study requirements

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 1 72 78 02 57 elisabeth.vacher@carmatsas.com

Locations
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Czechia
Institute for Clinical and Experimental Medicine Recruiting
Prague, Czechia, 140 21
Contact: Ivan Netuka, MD         
Denmark
Righospitalet, Recruiting
Copenhagen, Denmark
Contact: Finn Gustafsson, MD         
Kazakhstan
"National Research Cardiac Surgery Center" Recruiting
Astana, Kazakhstan, 010000
Contact: Yuriy Pya, MD         
Sponsors and Collaborators
Carmat SA
Investigators
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Study Director: Piet Jansen, MD, PhD Carmat SA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carmat SA
ClinicalTrials.gov Identifier: NCT02962973    
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: October 14, 2019
Last Verified: February 2019
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