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 beginning of the implant procedure is defined as the start of the…
ID
Source
Brief title
Condition
- Heart failures
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival at 180 days after Carmat TAH implantation.
Secondary outcome
- Overall survival
- Health status change as measured by EuroQol, EQ-5D-5L and SF36
- Functional status change as measured by NYHA and 6MWT
- Adverse events incidence and frequency
- Time to first discharge and incidence of re-hospitalization
Background summary
For the most severe forms of cardiac dysfunction, which lead to irreversible
biventricular failure, cardiac transplantation remains the only effective
therapy. There is a significant shortfall in the availability of human donor
hearts. Mechanical circulatory support (MCS) devices considered for patients
with advanced HF include VADs and TAHs. The type of device used depends on the
stage of HF and whether one or both ventricles are affected. Currently, the
SynCardia device is the only approved TAH on the market. This first generation
of Total Artificial Hearts (TAH) are pneumatically-driven and have been used as
a bridge to transplantation, at the cost of high morbidities related to the
devices. Carmat has developed a biocompatible, biventricular mechanical heart
that is designed to replicate the functionality and morphology of the human
heart as closely as possible using self-regulatory mechanisms and biocompatible
materials.
Study objective
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 beginning of the implant procedure is defined as the
start of the sternotomy. ** A patient will be considered to have survived to
heart transplant when anesthetic induction for heart transplant has started.
The purpose of this clinical study is to demonstrate safety and performance of
the Carmat TAH in patients with advanced heart failure.
Study design
This is a prospective, international multi-center, interventional, single-arm
study. After a screening process, subjects will be enrolled in the clinical
study if they meet clinical and anatomic criteria. In case of screening
failure, subjects will be followed in an observational phase for outcomes data
(e.g. survival, therapeutic option). Patients will be evaluated at 6 months
(180 days) for primary and secondary endpoints with further follow-up
assessments up to 2 years.
Intervention
Screening, baseline, implant and hospitalization period until discharge,
evaluation visit at 1M, 2M, 3M, 4M, 5M, 6M, 9M, 12M, 18M en M24
post-implantation.
Study burden and risks
The Carmat Total Artificial Heart (TAH) is an integrated
electro-hydraulically-driven system intended for full cardiac support in
patients suffering from advanced heart failure. The key features of the device
are the following: 1. First auto-regulated, sensorbased functioning TAH 2.
Designed for optimized haemocompatibility 3. Designed for patient comfort and
mobility. The Carmat TAH is intended for patients suffering from irreversible
bi-ventricular heart failure, either transplant-eligible (mid-term duration
support) or non-eligible (long-term/definitive support). It is designed for
in-hospital and out-of-hospital use.
36, avenue de l'Europe Immeuble l'Etendard
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FR
36, avenue de l'Europe Immeuble l'Etendard
Vélizy-Villacoublay Cedex 78941
FR
Listed location countries
Age
Inclusion criteria
1) Patient age: 18 to 75 years
2) Inotrope dependent or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are
contraindicated (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:
a. 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
b. Treatment-refractory recurrent and sustained ventricular tachycardia or
ventricular fibrillation in the presence of untreatable arrhythmogenic
pathologic substrate
c. 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 up 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 or
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) Severe End-organ dysfunction as per any of the following criteria:
a. Total bilirubin > 100 µmol/L (5,8 mg/dl) or cirrhosis evidenced by
ultrasound, CT-scan and positive biopsy
b. 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 (women of childbearing age will have to show
negative pregnancy test)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02962973 |
| CCMO | NL74452.041.20 |