Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 10
- 主要终点
- absence of re-intervention on the pulmonary valve
研究概览
简要总结
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.
This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.
详细描述
This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation).
排除标准
- •Patient or legal representative refusal to data collection or processing
- •Patient unable to guarantee follow-up data collection, in particular for patients living abroad
结局指标
主要结局
absence of re-intervention on the pulmonary valve
时间窗: 12 months
to evaluate the efficacy of the MELODY valve, defined as the absence of re-intervention on the pulmonary valvee
次要结局
- rate re-intervention on the valve(60 months)
- patient characteristics(60 months)
- survival rate at 12, 36, 48 and 60 months(60 months)
- frequency of antiplatelet treatment during and after implant(60 months)
- Description and time of onset of open surgery after implantation(60 months)
- failures of the implantation procedure(60 months)
- patients' characteristics to indications of the MELODY™ bioprosthesis(60 months)
- time period before the resumption of professional, university or scholastic activity(60 months)
- time period before re-intervention on the valve(60 months)