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Trial record 1 of 1 for:    CAR2016-01
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02962973
Recruitment Status : Suspended (Occurrence of a quality issue affecting some of its prostheses)
First Posted : November 15, 2016
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Carmat SA

Tracking Information
First Submitted Date  ICMJE November 8, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date January 6, 2022
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • Overall survival [ Time Frame: 180 days ]
    Patient follow-up
  • 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.
  • 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.
  • Functional status change [ Time Frame: 180 days ]
    New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)
  • 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.
  • Adverse events [ Time Frame: 180 days ]
    Adverse Event Rates will be captured per the INTERMACS definitions
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • Evolution of the NHYA classicafication [ Time Frame: 180 days ]
    NYHA classification will be assessed at baseline and 1, 3, 6 months post-implant
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE European Clinical Evaluation of the Carmat Total Artificial Heart
Official Title  ICMJE Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Heart Failure
Intervention  ICMJE
  • Device: CARMAT TAH
  • Procedure: Surgical intervention
Study Arms  ICMJE 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.
Interventions:
  • Device: CARMAT TAH
  • Procedure: Surgical intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2016)
10
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and Impella
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Denmark,   France,   Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02962973
Other Study ID Numbers  ICMJE CAR2016-01
CIV-FR-16-09-016865 ( Other Identifier: EUDAMED )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Carmat SA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Carmat SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Piet Jansen, MD, PhD Carmat SA
PRS Account Carmat SA
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP