Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
This study compares clinical, self- reported and cost outcomes in children and adolescents treated with pulmonary valve implantation, percutaneous versus open surgical technique. Since cardiac surgery in children and adolescents affect the whole family, the experience of the patients and their closest relatives are recorded and analysed separately. Cost may be an important factor in the choice of technology (1). Hence, the present study also aims to compare savings in costs, percutaneous versus open technique, related to the individual, their family and society.
1.2 Research questions
- Percutaneous pulmonary valve implantation or open heart surgery; what are the patients' and their closest relatives narrative experiences
- Is there a difference in patient and their closest relatives reported outcomes, measured as health related quality of life, in patients with congenital pulmonary disease before the event, 1, 3, 6 and 12 months after percutaneous intervention versus open heart surgery approach?
- What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment?
- Are there savings in costs related to the individual and their family and society between the two techniques?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •secure indication of pulmonary valve dysfunction (stenosis and, or regurgitation)
- •an indication of surgical correction
- •body weight according to the recommendation from the producer of the device
- •moderate to serious dilatation of right ventricle
- •considerable leak in the tricuspidal valve
- •information from former surgery; conduit size, gradient of the stenosis measured by EKKO/MR/ catheterization, X-ray.
- •be able to speak and communicate well in Norwegian.
排除标准
- •aggressive endocarditis
- •not circumferential deposit of calcium
- •not able to understand, speak or communicate well in Norwegian
结局指标
主要结局
Quality of life
时间窗: up to 12 month's after treatment
Percutaneous pulmonary valve implantation or open heart surgery; what are the patients and their closest relatives narrative experiences. Measured before the event, 1, 3, 6, and 12 month's after treatment.
次要结局
- Clinical outcomes(up to 12 months after treatment)
- Are there savings in costs related to the individual and their family and society between the two techniques?(up to 12 months after surgery)
研究者
Brith Andresen
CNS, MNSc
Oslo University Hospital