Prince of Wales Hospital Structural Heart Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorPrince of Wales Hospital, Shatin, Hong Kong

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Structural heart interventions

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Subject1 intervention

Trial outcomes

Primary outcomes

1

Procedural success rate

Procedural success rate

Time frame
Post-procedure until 1 year post OP
2

Procedural safety endpoints

Rate of vascular complication in enrolled subjects , ,

Time frame
Post-procedure until 1 year post OP
3

Procedural safety endpoints

Rate of myocardial infarction in enrolled subjects

Time frame
Post-procedure until 1 year post OP
4

Procedural safety endpoints

Rate of stroke in enrolled subjects

Time frame
Post-procedure until 1 year post OP

Secondary outcomes

1

Clinical outcome

NTproBNP at 3 months

Time frame
3 months
2

Clinical outcome

NYHA class at 3 months

Time frame
3 months
3

Clinical outcome

NTproBNP at 12 months

Time frame
12 months
4

Clinical outcome

NYHA class at 12 months

Time frame
12 months

Other outcomes

Sponsors and contacts

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