Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
研究概览
简要总结
This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).
详细描述
Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.
Main objective : evaluate the cost of the procedure as compared with conventional technique.
Design : multicenter intervention prospective study. Population : 180 patients in three arms (3*60).
End point criteria :
- Primary : cost
- Secondary : rate of reoperation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for the study:
- •Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation
- •for the Melody arm:
- •A 5 to 70 years old patient
- •Weight >= 30kg
- •RVOT <= to 22mm
- •Patient with a dysfunction circumferential prosthetic conduct of diameter >= to 16mm.
排除标准
- •Vein anatomy incompatibility with a 22Fr delivery health
- •Left heart implantation
- •RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
- •Coronary anomaly with a coronary artery naer the RVOT
- •Sever obstruction of the RVOT incompatible with balloon expansion
- •Central vein obstruction
- •Ongoing infection
- •Active endocarditis
- •Allergy for heparin or aspirin
- •Pregnancy
研究组 & 干预措施
Melody
insertion of a pulmonic valved stent
干预措施: Melody (Device)
Bare stent
insertion of a bare metal stent
干预措施: bare stent (Device)
Surgery
conventional surgery methode.
干预措施: Surgery (Procedure)
结局指标
主要结局
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
时间窗: 24 months after intervention
次要结局
- Quality of life(24 months after intervention)
- Does the patient need to be operated again?(24 months after intervention)
- procedure success rate(24 months after intervention)