Study of Transcatheter Tricuspid Annular Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Reduction in tricuspid regurgitation at 30 days
研究概览
简要总结
The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.
详细描述
The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation. The study is a prospective, multi-center safety and performance study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, and 1 year post implant procedure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)
- •Age≥18 and ≤85 years old
- •New York Heart Association (NYHA) Class II, III or ambulatory IV
- •Left ventricular ejection fraction (LVEF) ≥30%
- •Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)
- •Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR
- •Patient provides written Informed Consent before any study-specific tests or procedures are performed
- •Patient is willing and able to comply with all specified study evaluations
排除标准
- •Pregnant or lactating female
- •Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
- •Previous tricuspid valve repair or replacement
- •Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
- •Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
- •Life expectancy of less than 12-months
- •Severe right heart dysfunction
- •Pulmonary hypertension with PA mean 2/3 rd MAP
- •Active systemic infection
- •Pericardial infection
- •Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
- •Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression)
- •Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
- •Haemodynamic instability: systolic blood pressure <90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
- •Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months
- •Cerebrovascular event within the past 6 months
- •History of mitral/tricuspid endocarditis within the last 12 months
- •Organic tricuspid disease
- •Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
- •Known alcohol or drug abuser
- •Currently participating in the study of an investigational drug or device
结局指标
主要结局
Reduction in tricuspid regurgitation at 30 days
时间窗: 30 days
The reduction in the degree of tricuspid regurgitation compared to baseline measured post-procedure, at post-operative hospital discharge and at 1 month post-operative. Ability to reduce tricuspid regurgitation by at least 1 degree by means of quantitative echocardiographic parameters
Major Adverse Events
时间窗: 30 days
The percentage of participants with Major Adverse Events within 30 days of the procedure: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed MIA implantation, or stroke
次要结局
- Quality of Life Measurement(3 months)
- Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)(3 months)
- Reduction in tricuspid regurgitation(3 months)