Prince of Wales Hospital Structural Heart Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Procedural success rate
研究概览
简要总结
Structural heart disease refers to a group of cardiac defects other than coronary artery disease. Structural heart intervention is a rapidly growing field in cardiology. In the past decade, there has been paradigm shift in the management of structural heart disease from conventional open-heart surgery to transcatheter interventions. With increasing evidence supporting structural heart interventions including transcatheter aortic valve implantation or transcatheter edge to edge repair, there has important updates in recent guidelines in treating structural heart disease. Besides, new device innovations bloomed over the past few years and had expanded the possible treatment options for high surgical risk patients. Some breakthrough devices had been approved recently by the US Food and Drug Administration and some other devices are occasionally used on compassionate ground. However, there has been lack of data in structural heart interventions in Asia Pacific regions outside Japan [8]. In this study, we would like to analyze the epidemiological trends, patient characteristics, procedural outcomes and clinical outcomes of structural heart interventions, and compare them with historical cohorts, matched cohort receiving medical therapy and matched cohort receiving open heart surgeries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing structural heart interventions at the Prince of Wales Hospital
排除标准
- •Patients that are not able to consent.
研究组 & 干预措施
Subject
Structural heart intervensions
干预措施: Structural heart interventions (Procedure)
结局指标
主要结局
Procedural success rate
时间窗: Post-procedure until 1 year post OP
Procedural success rate
Procedural safety endpoints
时间窗: Post-procedure until 1 year post OP
Rate of vascular complication in enrolled subjects , ,
次要结局
- Clinical outcome(3 months)
- Clinical outcome(12 months)
- Echocardiogram outcome(12 months)
- Echocardiogram outcome(3 months)
研究者
Dr So Chak Yu kent
Principle investigator
Prince of Wales Hospital, Shatin, Hong Kong
