NCT02962973暂停不适用
Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure
Carmat SA4 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Proportion of participants with survival at 180 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age: 18 to 75 years
- •Inotrope dependent or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).
- •On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/AHA)
- •Eligible to biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support:
- •Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:
- •RVSWI ≤ 0.25 mmHg*L/m2
- •TAPSE ≤ 14mm
- •RV-to-LV end-diastolic diameter ratio > 0.72
- •CVP > 15 mmHg
- •CVP-to-PCWP ratio > 0.63
- •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)
- •Patient's affiliation to health care insurance, if local requirement
- •Patient has signed the informed consent and committed to follow study requirements
排除标准
- •Body Mass Index (BMI) < 15 or > 47
- •Existence of any ongoing non-temporary mechanical circulatory support
- •Existence of any temporary mechanical circulatory support other than IABP and Impella
- •History of cardiac or other organ transplant
- •Patients who have required cardiopulmonary resuscitation for > 30 minutes within 14 days prior to implant
- •Known intolerance to anticoagulant or antiplatelet therapies
- •Coagulopathy defined by platelets < 100k/μl or INR ≥ 1.5 not due to anticoagulant therapy
- •Cerebro-vascular accident < 3 months or symptomatic or a known > 80% carotid stenosis
- •Known abdominal or thoracic aortic aneurysm > 5 cm
- •End-organ dysfunction as per investigator judgment and following but not limited criteria:
- •Total bilirubin > 100 μmol/L (5,8 mg/dl) or cirrhosis evidenced by ultrasound, CT-scan or positive biopsy
- •GFR < 30ml/min/1.73m2
- •History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease
- •Recent blood stream infection (<7 days)
- •Documented amyloid light-chain (AL amyloidosis)
- •Hemodynamically significant peripheral vascular disease accompanied by rest pain or extremity ulceration
- •Illness, other than heart disease, that would limit survival to less than 1 year
- •Irreversible cognitive dysfunction, psychosocial issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management
- •Participation in any other clinical investigation that is likely to confound study results or affect the study
- •Pregnancy or breast feeding (woman in age of childbearing will have to show negative pregnancy test)
结局指标
主要结局
Proportion of participants with survival at 180 days
时间窗: 180 days
Success is defined as survival at 180 days after Carmat TAH implantation or transplanted if before 180 days.
次要结局
- Overall survival(180 days)
- General health status change (1)(180 days)
- Adverse events(180 days)
- hospital readmission rate(180 days)
- General health status change (2)(180 days)
- Change in functional status measured by the Six Minutes Walk Test(180 days)
- Functional status change(180 days)
研究者
研究点 (4)
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