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临床试验/NCT07020286
NCT07020286招募中不适用

Prince of Wales Hospital Structural Heart Registry

Prince of Wales Hospital, Shatin, Hong Kong2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年8月1日最近更新:
干预措施

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

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

发起方
Prince of Wales Hospital, Shatin, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr So Chak Yu kent

Principle investigator

Prince of Wales Hospital, Shatin, Hong Kong

研究点 (2)

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