The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 22
- 主要终点
- Procedural/Device related serious adverse events at 6 months
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.
详细描述
The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight greater than or equal to 30 kilograms
- •Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient >35mmHg by echocardiography
- •Main pulmonary artery trunk of ≥16 mm and ≤30 mm
- •Patients willing to provide written informed consent and comply with follow-up evaluations.
排除标准
- •Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation
- •Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
- •Obstruction of the central veins to be approached for the TPV implantation
- •Coronary artery compression confirmed by angiography
- •A known severe allergy to Nickel
- •A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
- •Suspected active infectious disease (e.g. endocarditis, meningitis)
- •Life expectancy of less than 6 months
研究组 & 干预措施
PULSTA TPV
PULSTA Transcatheter Pulmonary Valve (TPV) System
干预措施: PULSTA TPV System (Device)
结局指标
主要结局
Procedural/Device related serious adverse events at 6 months
时间窗: 6 months
Hemodynamic functional improvement at 6 months
时间窗: 6 months
Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction \<20% by cardiac magnetic resonance (MR)
次要结局
- Other adverse events(5 years)
- Pulmonary Regurgitant Fraction(6months)
- Severity of Pulmonary Regurgitation(5 years)
- NYHA functional classification(5 years)
- Reoperation(5 years)
- Procedural Success(7 days)
- Hemodynamic Function(5 years)
- Catheter reintervention on TPV(5 years)
- Procedural / Device related serious adverse events(5 years)
- Death (All cause / procedural/device-related)(5 years)