[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594503":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":60,"studyPopulation":64,"armGroups":65,"interventions":71,"overallOfficials":77,"centralContacts":82,"locations":88,"responsibleParty":107,"collaborators":60,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":60,"eligibilityCriteria":116,"healthyVolunteers":113,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":123,"studyType":124,"phases":60,"briefSummary":125,"conditions":126,"keywords":60,"overallStatus":91,"whyStopped":60,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":60},[9,12,15,17,19,21,23,25],{"measure":10,"description":10,"timeFrame":11},"Procedural success rate","Post-procedure until 1 year post OP",{"measure":13,"description":14,"timeFrame":11},"Procedural safety endpoints","Rate of vascular complication in enrolled subjects , ,",{"measure":13,"description":16,"timeFrame":11},"Rate of myocardial infarction in enrolled subjects",{"measure":13,"description":18,"timeFrame":11},"Rate of stroke in enrolled subjects",{"measure":13,"description":20,"timeFrame":11},"Rate of cardiac perforation in enrolled subjects",{"measure":13,"description":22,"timeFrame":11},"Rate of device embolization in enrolled subjects",{"measure":13,"description":24,"timeFrame":11},"Rate of death in enrolled subjects",{"measure":13,"description":26,"timeFrame":11},"Rate of conversion to open heart surgery in enrolled subjects",[28,32,34,37,39,42,44,46,48,50,52,54,56,58],{"measure":29,"description":30,"timeFrame":31},"Clinical outcome","NTproBNP at 3 months","3 months",{"measure":29,"description":33,"timeFrame":31},"NYHA class at 3 months",{"measure":29,"description":35,"timeFrame":36},"NTproBNP at 12 months","12 months",{"measure":29,"description":38,"timeFrame":36},"NYHA class at 12 months",{"measure":40,"description":41,"timeFrame":31},"Echocardiogram outcome","peri-device leak at post-OP 3 months compared with baseline",{"measure":40,"description":43,"timeFrame":31},"LVEF at post-OP 3 months compared with baseline",{"measure":40,"description":45,"timeFrame":31},"Valve residual regurgitation at post-OP 3 months compared with post-OP",{"measure":40,"description":47,"timeFrame":31},"Degree of Valve stenosis at post-OP 3 months compared with baseline",{"measure":40,"description":49,"timeFrame":36},"Degree of Valve stenosis at post-OP 12 months compared with baseline",{"measure":40,"description":51,"timeFrame":36},"Peri-device leak at post-OP 12 months",{"measure":40,"description":53,"timeFrame":36},"LVEF at post-OP 12 months compared with baseline",{"measure":40,"description":55,"timeFrame":36},"valve residual regurgitation at post-OP 12 months compared with baseline",{"measure":29,"description":57,"timeFrame":36},"NYHA class comparison with matched historical cohort at PWH\n\n* Clinical outcome comparison with medical therapy cohort at PWH\n* Clinical outcome comparison with surgical cohort at PWH\n* Clinical outcome comparison with matched cohort at HA",{"measure":29,"description":59,"timeFrame":36},"NTproBNP comparison with matched historical cohort at PWH\n\n* Clinical outcome comparison with medical therapy cohort at PWH\n* Clinical outcome comparison with surgical cohort at PWH\n* Clinical outcome comparison with matched cohort at HA",null,{"allocation":60,"interventionModel":60,"interventionModelDescription":60,"primaryPurpose":60,"observationalModel":62,"timePerspective":63,"maskingInfo":60},"COHORT","PROSPECTIVE","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.",[66],{"label":67,"type":60,"description":68,"interventionNames":69},"Subject","Structural heart intervensions",[70],"Procedure: Structural heart interventions",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":60},"PROCEDURE","Structural heart interventions","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.",[67],[78],{"name":79,"affiliation":80,"role":81},"Daniel Xu, Research Nurse","Chinese University of Hong Kong","STUDY_DIRECTOR",[83],{"name":84,"role":85,"phone":86,"phoneExt":60,"email":87},"Kent So, PI","CONTACT","85235051518","kentso@cuhk.edu.hk",[89],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":92,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Prince of Wales Hospital","RECRUITING","Hong Kong","Shatin","0000","HK",{"type":97,"coordinates":98},"Point",[99,100],114.17469,22.27832,{"lat":100,"lon":99},[103],{"name":104,"role":85,"phone":105,"phoneExt":60,"email":106},"Chak Yu So","85260338536","kentso987@gmail.com",{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"PRINCIPAL_INVESTIGATOR","Dr So Chak Yu kent","Principle investigator","100594503","prince-of-wales-hospital-structural-heart-registry-100594503",false,"NCT07020286","Prince of Wales Hospital Structural Heart Registry","Inclusion Criteria:\n\n* All patients undergoing structural heart interventions at the Prince of Wales Hospital\n\nExclusion Criteria:\n\n* Patients that are not able to consent.","ALL","18 Years","90 Years",{"count":121,"type":122},1000,"ESTIMATED","1 Year","OBSERVATIONAL","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.",[127],"Structural Heart Abnormality","2026-09-15",{"date":130,"type":131},"2026-09-16","ACTUAL",{"date":133,"type":131},"2024-08-01",{"date":135,"type":122},"2030-03-31",{"name":5,"class":6},1]