Prince of Wales Hospital Structural Heart Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structural heart interventions.
- Who it may be relevant to
- Registry conditions: Structural Heart Abnormality. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Structural heart 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.
Primary outcome measures
- Procedural success rate [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
- Procedural safety endpoints [Time frame: Post-procedure until 1 year post OP]
Secondary outcome measures (12)
- Clinical outcome [Time frame: 3 months]
- Clinical outcome [Time frame: 3 months]
- Clinical outcome [Time frame: 12 months]
- Clinical outcome [Time frame: 12 months]
- Echocardiogram outcome [Time frame: 3 months]
- Echocardiogram outcome [Time frame: 3 months]
- Echocardiogram outcome [Time frame: 3 months]
- Echocardiogram outcome [Time frame: 3 months]
- Echocardiogram outcome [Time frame: 12 months]
- Echocardiogram outcome [Time frame: 12 months]
- Echocardiogram outcome [Time frame: 12 months]
- Echocardiogram outcome [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- All patients undergoing structural heart interventions at the Prince of Wales Hospital
Exclusion criteria
- Patients that are not able to consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT07020286 · 2024.199