An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Procedural / device-related serious adverse events at 12 months
研究概览
简要总结
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
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. This registry will collect real-world clinical data on patients undergoing PULSTA TPV implantation at discharge and at 1 month, 6 months, and annually for up to 5 years after implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA Transcatheter Pulmonary Valve(TPV).
- •Patients who are willing to participate in the study and who have voluntarily provided written informed consent.
排除标准
- •Patients who have not signed informed consent
- •Patients who are contraindicated for the implantation per the device's Instructions for Use.
研究组 & 干预措施
PULSTA TPV Recipients
Single-arm cohort consisting of all eligible patients undergoing percutaneous pulmonary valve implantation(PPVI) with the PULSTA TPV as part of routine clinical care
结局指标
主要结局
Procedural / device-related serious adverse events at 12 months
时间窗: 12 months
Hemodynamic functional improvement at 12 months
时间窗: 12 months
Hemodynamic functional improvement is defined as the achievement of both of the following criteria: * Mild or less pulmonary regurgitation measured by echocardiography AND * Mean Right Ventricular Outflow Tract(RVOT) pressure gradient measured by echocardiography ≤35mmHg
次要结局
- Hemodynamic function at all follow-up visits(5 years)
- Severity of pulmonary regurgitation (by echocardiography)(5 years)
- NYHA functional classification(5 years)
- Freedom from death(5 years)
- Freedom from re-operation(5 years)
- Freedom from catheter re-intervention(5 years)
- Freedom from TPV dysfunction(5 years)
- Incidence of procedural- and device-related adverse events(5 years)
- Procedural success(24 hours)