Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Clinical Utility and Cost, as a Bridge to Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- Survival free of disabling stroke at 180 days post-implant
研究概览
简要总结
The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.
详细描述
A selection committee (composed of minimum two experts in the field of cardiovascular surgery/cardiology and of PIs) assess the subject eligibility based on clinical and anatomic criteria. Clinically eligible patients will be distributed into two cohorts depending on their anatomic compatibility with the device:
- cohort 1: patients that are anatomically compatible will receive the Carmat TAH ;
- cohort 2: patients that are not anatomically compatible will receive standard therapy
The efficacy and safety of the Carmat TAH will be assessed in cohort 1 and compared to a level of efficacy defined by the published data on the commercially available TAH; and adjusted for INTERMACS patient profile.
The clinical utility and the costs of Carmat TAH will be assessed by comparing the cohort of subject receiving the Carmat TAH to the cohort of patients treated by standard therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years or older
- •Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant
- •On inotropes or cardiac Index (CI) < 2.2 L/min/m2
- •On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/HAS)
- •Eligible to biventricular Mechanical Circulatory Support according to one of the following category:
- •Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:
- •RVEF ≤ 30% or FAC < 35%
- •RVSWI ≤ 0.25 mmHg*L/m2
- •TAPSE ≤ 14mm
- •RV-to-LV end-diastolic diameter ratio > 0.72
- •CVP > 15 mmHg or persistence of echographic and/or biological signs of hepatic congestion
- •CVP-to-PCWP ratio > 0.63
- •PAP index <2
- •Tricuspid insufficiency grade 4
- •Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
- •Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis / senile or other infiltrative heart disease)
- •Anatomic compatibility confirmed using 3D imaging (CT-scan) and by the screening committee (for Cohort 1).
- •Patient's affiliation to health care insurance
- •Patient has signed the informed consent.
排除标准
- •Absolute contra-indication for heart transplant
- •Existence of any ongoing non-temporary mechanical circulatory support
- •Existence of any ongoing peripheral mechanical circulatory support such as ECMO, Impella (all types), IABP with a support duration > 21 days
- •Patient intubated and unconscious; or intubated and not awake
- •Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
- •Coagulopathy defined by platelets < 100G/l or INR ≥ 1.5 not due to anticoagulant therapy.
- •Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent venous thromboembolic events requiring long term curative oral anticoagulation.
- •Cerebrovascular accident < 3 months or symptomatic (Rankin score >1; Glasgow score < 14) or a known > 80% carotid stenosis.
- •Known abdominal or thoracic aortic aneurysm > 5 cm that has not been treated.
- •Severe end-organ dysfunction as per the following criteria:
- •Total bilirubin > 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound, IRM and positive biopsy
- •GFR < 30ml/min/1.73m2 (with no hemodialysis)
- •History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease with FEV1/FVC <0.7 and FEV1<50% predicted.
- •Recent active blood stream infection confirmed by a positive hemoculture within 48 hours.
- •Documented amyloid light-chain (AL amyloidosis).
- •Hemodynamically significant peripheral vascular disease assessed by clinical exam.
- •Illness, other than heart disease, that would limit survival to less than 2 years.
- •Irreversible cognitive dysfunction, psycho-cognitive disabilities, psycho-social issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management that in the opinion of the investigator could interfere with the ability to manage the therapy (i.e. non-compliance to heart failure therapy, uncontrolled diabetes, mental health issue, etc.).
- •Pregnancy or breast feeding (woman in childbearing age will have to show negative pregnancy test).
- •Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound the study results or affect the study.
研究组 & 干预措施
Carmat TAH (Cohort 1)
Subjects implanted with Carmat TAH
干预措施: Carmat Total Artificial Heart (Device)
Standard Therapy (cohort 2)
Standard Therapy
干预措施: Standard therapy for heart failure (Other)
结局指标
主要结局
Survival free of disabling stroke at 180 days post-implant
时间窗: 180 days
Success is defined as survival free of disabling stroke (Modified Rankin score \>3) at 180 days after Carmat TAH implantation or transplanted if before 180 days.
Survival free of disabling stroke and free of reoperation for device malfunction at 180 days post-implant
时间窗: 180 days
Success is defined as survival free of disabling stroke (Modified Rankin score \>3) and free of device malfunction leading to a reoperation for device replacement or urgent transplantation, or electively transplanted within 180 days after Carmat TAH implantation
次要结局
- Change in functional status measured by the Six Minutes Walk Test(180 days - 1 and 2 years)
- General Health Status change(180 days - 1 and 2 years)
- Hospital re-admissions rate(180 days - 1 and 2 years)
- Overall survival(180 days - 1 year)
- Adverse Events(180 days - 1 and 2 years)
- Quality Adjusted Life Years(180 days - 1 and 2 years)
- Change in functional status(180 days - 1 and 2 years)
- Healthcare costs(180 days - 1 and 2 years)
- Overall survival(180 days - 1 year - 2 years)
- Healthcare costs(1 and 2 years)
- Quality Adjusted Life Years(1 and 2 years)