Structural Heart AbnormalityNCT07020286
Prince of Wales Hospital Structural Heart Registry
An observational study of Structural Heart Abnormality, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Structural Heart Abnormality
- What is being tested?
- Structural heart interventions
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2024to 31 Mar 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All patients undergoing structural heart interventions at the Prince of Wales Hospital
Who cannot join
- Patients that are not able to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Shatin, 0000
Chak Yu So, 85260338536, kentso987@gmail.com
About this study
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.
- Conditions
- Structural Heart Abnormality
- Being tested
- Structural heart interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural heart interventionsProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Subject | Structural heart intervensions Receives: Procedure: Structural heart interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
Procedural success rate
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of vascular complication in enrolled subjects , ,
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of myocardial infarction in enrolled subjects
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of stroke in enrolled subjects
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of cardiac perforation in enrolled subjects
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of device embolization in enrolled subjects
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of death in enrolled subjects
Measured: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of conversion to open heart surgery in enrolled subjects
Measured: Post-procedure until 1 year post OP
Secondary outcomes (14)
Clinical outcome
NTproBNP at 3 months
Measured: 3 months
Clinical outcome
NYHA class at 3 months
Measured: 3 months
Clinical outcome
NTproBNP at 12 months
Measured: 12 months
Clinical outcome
NYHA class at 12 months
Measured: 12 months
Echocardiogram outcome
peri-device leak at post-OP 3 months compared with baseline
Measured: 3 months
Echocardiogram outcome
LVEF at post-OP 3 months compared with baseline
Measured: 3 months
Echocardiogram outcome
Valve residual regurgitation at post-OP 3 months compared with post-OP
Measured: 3 months
Echocardiogram outcome
Degree of Valve stenosis at post-OP 3 months compared with baseline
Measured: 3 months
Echocardiogram outcome
Degree of Valve stenosis at post-OP 12 months compared with baseline
Measured: 12 months
Echocardiogram outcome
Peri-device leak at post-OP 12 months
Measured: 12 months
Echocardiogram outcome
LVEF at post-OP 12 months compared with baseline
Measured: 12 months
Echocardiogram outcome
valve residual regurgitation at post-OP 12 months compared with baseline
Measured: 12 months
Clinical outcome
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
Measured: 12 months
Clinical outcome
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Aug 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart AbnormalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Daniel Xu, Research Nurse, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020286
- Sponsor's protocol ID
- 2024.199
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prince of Wales Hospital Structural Heart Registry
- ClinicalTrials.gov ID
- NCT07020286
- Acronym / sponsor ID
- 2024.199
- Conditions
- Structural Heart Abnormality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject | – | Procedure: Structural heart interventionsStructural heart intervensions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients undergoing structural heart interventions at the Prince of Wales Hospital
Key exclusion criteria (1 listed)
- Patients that are not able to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural heart interventionsThe 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. | Procedure or surgery | Subject |
Primary outcome
Procedural success rate
Time frame: Post-procedure until 1 year post OP
Procedural success rate
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of vascular complication in enrolled subjects , ,
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of myocardial infarction in enrolled subjects
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of stroke in enrolled subjects
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of cardiac perforation in enrolled subjects
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of device embolization in enrolled subjects
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of death in enrolled subjects
Procedural safety endpoints
Time frame: Post-procedure until 1 year post OP
Rate of conversion to open heart surgery in enrolled subjects
14 secondary outcomes
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
Clinical outcome
Time frame: 12 months
Clinical outcome
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Xu, Research Nurse study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Structural Heart Abnormality, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kent So, PI (85235051518, kentso@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate (time frame: Post-procedure until 1 year post OP). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.