European Clinical Evaluation of the Carmat Total Artificial Heart

Advanced Heart Failure Clinical Trial

— ADVANCEHF  

Official title:

Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02962973
• Other study ID #: CAR2016-01
• Secondary ID: CIV-FR-16-09-016
• Status: Suspended
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Carmat SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure

Intervention

Device:
• CARMAT TAH

Procedure:
• Surgical intervention

Locations

Country	Name	City	State
Kazakhstan	"National Research Cardiac Surgery Center"	Astana
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Carmat SA

Countries where clinical trial is conducted

Kazakhstan,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with survival at 180 days	Success is defined as survival at 180 days after Carmat TAH implantation or transplanted if before 180 days.	180 days
Secondary	Overall survival	Patient follow-up	180 days
Secondary	General health status change (1)	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.	180 days
Secondary	General health status change (2)	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.	180 days
Secondary	Functional status change	New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)	180 days
Secondary	Change in functional status measured by the Six Minutes Walk Test	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.	180 days
Secondary	Adverse events	Adverse Event Rates will be captured per the INTERMACS definitions	180 days
Secondary	hospital readmission rate	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	180 days