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Enrolling by Invitation

NCT Number: NCT07020286

Prince of Wales Hospital Structural Heart Registry

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.

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Key information

Conditions

Structural Heart Abnormality

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong, Shatin, 0000

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing structural heart interventions at the Prince of Wales Hospital

Exclusion criteria

  • Patients that are not able to consent.

Treatment and study plan

Structural heart interventions

Procedure

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 outcomes

  1. Procedural success rate

    Time frame: Post-procedure until 1 year post OP

    Procedural success rate

  2. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of vascular complication in enrolled subjects , ,

  3. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of myocardial infarction in enrolled subjects

  4. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of stroke in enrolled subjects

  5. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of cardiac perforation in enrolled subjects

  6. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of device embolization in enrolled subjects

  7. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of death in enrolled subjects

  8. Procedural safety endpoints

    Time frame: Post-procedure until 1 year post OP

    Rate of conversion to open heart surgery in enrolled subjects

Secondary outcomes

  1. Clinical outcome

    Time frame: 3 months

    NTproBNP at 3 months

  2. Clinical outcome

    Time frame: 3 months

    NYHA class at 3 months

  3. Clinical outcome

    Time frame: 12 months

    NTproBNP at 12 months

  4. Clinical outcome

    Time frame: 12 months

    NYHA class at 12 months

  5. Echocardiogram outcome

    Time frame: 3 months

    peri-device leak at post-OP 3 months compared with baseline

  6. Echocardiogram outcome

    Time frame: 3 months

    LVEF at post-OP 3 months compared with baseline

  7. Echocardiogram outcome

    Time frame: 3 months

    Valve residual regurgitation at post-OP 3 months compared with post-OP

  8. Echocardiogram outcome

    Time frame: 3 months

    Degree of Valve stenosis at post-OP 3 months compared with baseline

  9. Echocardiogram outcome

    Time frame: 12 months

    Degree of Valve stenosis at post-OP 12 months compared with baseline

  10. Echocardiogram outcome

    Time frame: 12 months

    Peri-device leak at post-OP 12 months

  11. Echocardiogram outcome

    Time frame: 12 months

    LVEF at post-OP 12 months compared with baseline

  12. Echocardiogram outcome

    Time frame: 12 months

    valve residual regurgitation at post-OP 12 months compared with baseline

  13. Clinical outcome

    Time frame: 12 months

    NYHA class comparison with matched historical cohort at PWH

    • Clinical outcome comparison with medical therapy cohort at PWH
    • Clinical outcome comparison with surgical cohort at PWH
    • Clinical outcome comparison with matched cohort at HA

  14. Clinical outcome

    Time frame: 12 months

    NTproBNP comparison with matched historical cohort at PWH

    • Clinical outcome comparison with medical therapy cohort at PWH
    • Clinical outcome comparison with surgical cohort at PWH
    • Clinical outcome comparison with matched cohort at HA

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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