A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 10
- 主要终点
- Hemodynamic functional improvement at 6month
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
详细描述
The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post 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 pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient >35mmHg by echocardiography
- •pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm
- •Patient willing to provide written informed consent and comply with follow-up requirements
排除标准
- •Pre-existing mechanical heart valve in any position
- •Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)
- •Coronary artery compression
- •A known hypersensitivity to Aspirin or Heparin
- •Immunosuppressive disease
- •Active infectious disease (e.g. endocarditis, meningitis)
- •Estimated survival less than 6 months
- •Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
研究组 & 干预措施
Pulsta® Transcatheter Pulmonary Valve
Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)
干预措施: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement (Device)
结局指标
主要结局
Hemodynamic functional improvement at 6month
时间窗: 6 months
Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction \<20% by cardiac magnetic resonance (MR).
Procedural / Device related serious adverse events at 6month
时间窗: 6 months
次要结局
- Procedural success(5 days)
- Hemodynamic function(5 years)
- Severity of pulmonary regurgitation(5 years)
- New York Heart Association (NYHA) functional classification(5 years)
- Catheter reintervention on TPV(5 years)
- Reoperation(5 years)
- Death (all cause / procedural / device-related)(5 years)
- Other adverse events(5 years)
- Procedural / Device related serious adverse events(5 years)
- Pulmonary regurgitant fraction(6 months)
- Stent fracture(5 years)