Multi-center Trial of Percutaneous Pulmonary Valve Implantation Using Venus-P Valve for Patients With Severe Pulmonary Regurgitation and Native Right Ventricular Outflow Tract After Previous Surgical Repair
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- right ventricular end diastolic volume index
研究概览
简要总结
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and native right ventricular outflow tract (RVOT) after surgical repair of RVOT.
详细描述
Clinical experience to date with transcatheter pulmonary valve replacement has been limited to two balloon expandable systems, namely the Melody Valve (Medtronic Inc, Minneapolis, MN) and the Sapien valve (Edwards Lifesciences, Irvine, CA). Both valves have undergone clinical trials with good medium-term valve durability. Although both the Melody and the Sapien valves have been used in native outflow tracts with good success , limitations to the extended application of these valves have generally centered on the maximum diameter of the RVOT. Indeed in the majority of patients requiring pulmonary valve replacement (PVR), these balloon expandable systems are not large enough to maintain stable valve position within the dilated native RVOT.Therefore more recent efforts have concentrated on a self-expanding system to provide valve competence despite significant dilation of the native RVOT.
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the trial is to evaluate the safety and efficacy of the Venus-P Valve for PPVI in patients pulmonary regurgitation and native RVOT after surgical repair of RVOT.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract obstruction with trans-annulus or RVOT patch;
- •right ventricular diastolic volume index: 130-160 mL/m2 measured by isotopic examination or cardiac MRI measurements;
- •Age: ≥10 years and ≤60 years;
- •Weight ≥18 Kg;
- •Pulmonary annulus : 14- 31 mm;
- •RVOT length ≥20mm ;
- •Signing the informed consent;
- •Any of the following conditions: ① symptomatic, ②progressive RV systolic dysfunction, ③ progressive tricuspid regurgitation (at least moderate), ④ RVOT obstruction with RV systolic pressure ≥80 mmHg, ⑤ Sustained atrial/ventricular arrhythmias.
排除标准
- •Pre-existing pulmonary artery stenosis or artificial pulmonary valve at any position;
- •Severe chest wall deformity (funnel chest, etc.);
- •Acute uncompensated heart failure;
- •Active infection or endocarditis requiring antibiotic therapy;
- •Leukopenia (white blood cell <3000 mm3);
- •Acute or chronic anemia (hemoglobin <9 g/L);
- •Platelet counts <10000 /mm3;
- •Impossibly of delivering Venus-P to RVOT as judged by researcher s before procedure;
- •Known allergy to aspirin or heparin;
- •Positive urine or serum pregnancy test in female subjects.
结局指标
主要结局
right ventricular end diastolic volume index
时间窗: 6 months
次要结局
- Incidence of adverse cardiovascular events(48 hours)
- Incidence of deaths or strokes(12 months)
- pulmonary pressure gradient(1,3,6,12 months)
- grade of pulmonary regurgitation(1,3,6,12 months)
- New York Heart Association (NYHA) class(1,3,6,12 months)
- 6 minutes walk distance(1,3,6,12 months)