Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 24
- 主要终点
- Rate of Major Adverse Events [Safety endpoint]
研究概览
简要总结
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
详细描述
Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has clinically significant TR graded as severe or greater
- •Peak central venous pressure of ≥ 15mmHg
- •Patient has NYHA functional classification of III or IV
- •Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
排除标准
- •Patients will be excluded from participation if ANY of the following criteria apply:
- •Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.
- •Anatomical suitability according to CT scan.
- •Systolic Pulmonary Artery Pressure > 65mmHg
- •Moderate or more mitral valve stenosis
- •Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
- •Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
- •Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
- •Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
- •Thrombocytopenia (Platelet count< 80,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3) within 14 days of the index procedure
- •In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy < 12 months
结局指标
主要结局
Rate of Major Adverse Events [Safety endpoint]
时间窗: at the end of the procedure, at discharge - typically within a week, and 30 days
Rate of device or procedure-related Major Adverse Events (MAEs) And Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure
Technical Performance
时间窗: at the end of the procedure, at discharge - typically within a week, and 30 days
Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \[at the end of the procedure\] And No need for re-intervention due to device valve regurgitation or para-stent leak \[at discharge, and 30 days\]
次要结局
- Rate of Major Adverse Events [Safety endpoint](at 3 months, 6 months, 1, 2, 3, 4, and 5 years)
- Efficacy endpoint(at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year)