Efficacy and Safety Evaluation of Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract (RVOT) Stenosis After Congenital Heart Defect Surgical Correction Complicated With Severe Pulmonary Regurgitation
试验速览
- 阶段
- 3 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Improvement rate of RVEDV at 6 months post-procedure.
研究概览
简要总结
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
详细描述
The aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve.
Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI) between 130-160mL/m2.
Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RVOT stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation
- •Isotopic or CMR criteria of RVEDVI≥130mL/m2 and ≤160mL/m2
- •Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years
- •Body weight≥18 kg
- •Pulmonary annular diameter between 14mm to 31mm
- •RVOT length≥20mm
- •The subject or his/her legal representative has provided written informed consent
- •Subject will comply with protocol required follow-ups
- •Add any of the following conditions:
- •Subject is symptomatic
- •Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI
- •≥3+ pulmonary regurgitation by echocardiograms
- •Deteriorating RVEF%
- •Progressive tricuspid valve regurgitation (at least moderate degree)
- •Complicated with RVOT obstruction (RV systolic pressure>80mmHg)
- •Persistent arrhythmias
排除标准
- •Candidates will be excluded from the study if any of the following conditions are present:
- •Existing pulmonary artery branch stenosis or artificial pulmonary valve
- •Severe chest wall deformity
- •Active infection or endocarditis requiring antibiotic therapy
- •Leukopenia (WBC<3000mm3)
- •Acute or chronic anemia (Hb<9g/L)
- •Platelet account <100,000 cells/mm3
- •In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
- •A known hypersensitivity to aspirin or heparin
- •Positive urine or serum pregnancy test in female subjects
- •Ileofemoral vessel characteristics that would preclude safe placement of introducer sheath
结局指标
主要结局
Improvement rate of RVEDV at 6 months post-procedure.
时间窗: At 6 months post-implantation of Venus-P valve
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
次要结局
- Safety Endpoints(From the date of implantation until 12 months post-procedure)