About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients undergoing structural heart interventions at the Prince of Wales Hospital
Disqualifiers
Patients that are not able to consent.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Structural heart interventions
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Procedural success rate
Procedural success rate
Procedural safety endpoints
Rate of vascular complication in enrolled subjects , ,
Procedural safety endpoints
Rate of myocardial infarction in enrolled subjects
Procedural safety endpoints
Rate of stroke in enrolled subjects
Secondary outcomes
Clinical outcome
NTproBNP at 3 months
Clinical outcome
NYHA class at 3 months
Clinical outcome
NTproBNP at 12 months
Clinical outcome
NYHA class at 12 months
Sponsors and contacts
Click on the lead sponsor to view all of their trials.