Prince of Wales Hospital Structural Heart Registry
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
November 26, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
June 13, 2025
June 1, 2025
5.2 years
November 26, 2024
June 5, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
Procedural success rate
Procedural success rate
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of vascular complication in enrolled subjects , ,
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of myocardial infarction in enrolled subjects
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of stroke in enrolled subjects
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of cardiac perforation in enrolled subjects
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of device embolization in enrolled subjects
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of death in enrolled subjects
Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of conversion to open heart surgery in enrolled subjects
Post-procedure until 1 year post OP
Secondary Outcomes (14)
Clinical outcome
3 months
Clinical outcome
3 months
Clinical outcome
12 months
Clinical outcome
12 months
Echocardiogram outcome
3 months
- +9 more secondary outcomes
Study Arms (1)
Subject
Structural heart intervensions
Interventions
The study allows us to understand the trend of transcatheter interventions in structural heart disease, clinical outcomes and allows the comparison of the outcomes of structural heart interventions to medical therapy and surgery at PWH, and to HA hospitals.
Eligibility Criteria
There is approximately 250 cases of structural heart intervention cases performed in 2023. The numbers are stable in the past 3 years. The dropout rate around 1-2% as reflected from other registry studies. Therefore, there would be around 1000 cases to be recruited during our 4 year recruitment period.
You may qualify if:
- All patients undergoing structural heart interventions at the Prince of Wales Hospital
You may not qualify if:
- Patients that are not able to consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Shatin, 0000, Hong Kong
Study Officials
- STUDY DIRECTOR
Daniel Xu, Research Nurse
Chinese University of Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
November 26, 2024
First Posted
June 13, 2025
Study Start
August 1, 2024
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
March 31, 2030
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD