Clinical trial NCT07020286: Prince of Wales Hospital Structural Heart Registry
Official title: Prince of Wales Hospital Structural Heart Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Structural Heart Abnormality
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


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.

Primary outcomes:
measure: Procedural success rate
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
measure: Procedural safety endpoints
timeFrame: Post-procedure until 1 year post OP
Secondary outcomes:
measure: Clinical outcome
timeFrame: 3 months
measure: Clinical outcome
timeFrame: 3 months
measure: Clinical outcome
timeFrame: 12 months
measure: Clinical outcome
timeFrame: 12 months
measure: Echocardiogram outcome
timeFrame: 3 months
measure: Echocardiogram outcome
timeFrame: 3 months
measure: Echocardiogram outcome
timeFrame: 3 months
measure: Echocardiogram outcome
timeFrame: 3 months
measure: Echocardiogram outcome
timeFrame: 12 months
measure: Echocardiogram outcome
timeFrame: 12 months
measure: Echocardiogram outcome
timeFrame: 12 months
measure: Echocardiogram outcome
timeFrame: 12 months
measure: Clinical outcome
timeFrame: 12 months
measure: Clinical outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
affiliation: Chinese University of Hong Kong
name: Daniel Xu, Research Nurse
role: STUDY_DIRECTOR
References: