TRICUS STUDY EURO - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- Kansas City Cardiomyopathy Questionnaire (KCCQ)
研究概览
简要总结
The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.
详细描述
TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy. Pre-Clinical and Clinical preliminary studies have shown an acceptable safety and performance profile of the TricValve® Transcatheter Bicaval Valves System. Given that the medical device is a potential long-term treatment for patients with tricuspid insufficiency, clinical data for long-term treatment periods is necessary. Thus, the current study with the aim of CE certification is designed to investigate the safety and performance for at least 30 days and up to 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be 18 years of age or older
- •The subject must be a patient with severe symptomatic tricuspid regurgitation demonstrated by echocardiography with significant backflow in the lower (IVC) and/or upper (SVC) vena cava and with a v-wave ≥ 25 mmHg as demonstrated by right heart catheterization (measured in the IVC and/or SVC 2-4 cm above/ below RA inflow) within 8 weeks prior to the implantation
- •Suitable for TricValve® Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography
- •The subjects must have severe, tricuspid regurgitation leading to NYHA class III or IV
- •The subject has LVEF ≥ 40%
- •Distance covert in 6-minute walk test (6MWT) ≥ 60m
- •The patient shall be screened by a "Heart Team" - including an interventional cardiologist, cardiothoracic surgeon, and agreed as a candidate for TricValve® Transcatheter Bicaval Valves System implantation
- •Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent
- •Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfil all of the expected requirements of this clinical protocol
- •Optimal medical treatment of patient
排除标准
- •Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart teams decision
- •Requirement for other elective cardiac procedures e.g. PCI (percutaneous treatment of coronary artery) or CABG (coronary artery bypass surgery) up to 90 days after the procedure or 30 days before the procedure
- •Right ventricular failure (TAPSE ≤13mmHg)
- •Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography
- •Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
- •Cerebro-vascular event within the past 3 months
- •History of mitral/tricuspid endocarditis within the last 12 months
- •Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
- •Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
- •Documented evidence of significant renal dysfunction (serum creatinine > 3.0mg/dl) or on any form of dialysis at time of screening within the last 4 weeks
- •Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately premedicated
- •Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
- •The patient has contraindication against a transesophageal echo (TEE) during the procedure
- •Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
- •Liver cirrhosis Child C (see appendix)
- •Female patient of child-bearing potential
- •Psychiatric or behavioural disease including known alcohol or drug abuser that is likely to impair compliance with protocol
- •Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study
- •Requirement for antibiotic treatment within the last 48 hours
结局指标
主要结局
Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: 3 months
Number of Patients with improvement in quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ, a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Range of 0-100, in which higher scores reflect better health status.)
Percentage of participants with major adverse events
时间窗: 30 days
The percentage of participants with major adverse events (death, myocardial infarction, cardiac tamponade, cardiac surgery for failed TricValve® implantation, stroke. Major bleeding according to Valve Academic Research Consortium (VARC) criteria)
次要结局
- Successful implantation(Up to Discharge (≤ 10 days post index procedure))
- Cusp insufficiency(Up to 30 days, up to 6 months)
- NYHA functional class(Up to 30 days)
- Percentage of participants with major adverse events(up to 6 months)
- Device success(Up to 30 days, up to 6 months)
- 6 Minute Walk Test(Up to 30 days, up to 6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Up to 6 months)
- Unrestricted movement of cusps(Up to 30 days, up to 6 months)