Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject | Structural heart intervensions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate | Procedural success rate | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of vascular complication in enrolled subjects , , | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of myocardial infarction in enrolled subjects | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of stroke in enrolled subjects | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of cardiac perforation in enrolled subjects | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of device embolization in enrolled subjects | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of death in enrolled subjects | Post-procedure until 1 year post OP |
| Procedural safety endpoints | Rate of conversion to open heart surgery in enrolled subjects | Post-procedure until 1 year post OP |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | NTproBNP at 3 months | 3 months |
| Clinical outcome | NYHA class at 3 months | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Xu, Research Nurse | Chinese University of Hong Kong | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Shatin | 0000 | Hong Kong |
No plan to share IPD
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Clinical outcome | NTproBNP at 12 months | 12 months |
| Clinical outcome | NYHA class at 12 months | 12 months |
| Echocardiogram outcome | peri-device leak at post-OP 3 months compared with baseline | 3 months |
| Echocardiogram outcome | LVEF at post-OP 3 months compared with baseline | 3 months |
| Echocardiogram outcome | Valve residual regurgitation at post-OP 3 months compared with post-OP | 3 months |
| Echocardiogram outcome | Degree of Valve stenosis at post-OP 3 months compared with baseline | 3 months |
| Echocardiogram outcome | Degree of Valve stenosis at post-OP 12 months compared with baseline | 12 months |
| Echocardiogram outcome | Peri-device leak at post-OP 12 months | 12 months |
| Echocardiogram outcome | LVEF at post-OP 12 months compared with baseline | 12 months |
| Echocardiogram outcome | valve residual regurgitation at post-OP 12 months compared with baseline | 12 months |
| Clinical outcome | NYHA class comparison with matched historical cohort at PWH
| 12 months |
| Clinical outcome | NTproBNP comparison with matched historical cohort at PWH
| 12 months |