[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595988":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":16,"studyPopulation":43,"armGroups":16,"interventions":44,"overallOfficials":16,"centralContacts":16,"locations":49,"responsibleParty":69,"collaborators":16,"id":71,"slug":16,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":16,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":16,"maxAge":16,"enrollmentInfo":78,"targetDuration":16,"studyType":81,"phases":16,"briefSummary":74,"conditions":82,"keywords":16,"overallStatus":52,"whyStopped":16,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Pulnovo Medical (Wuxi) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical worsening","Clinical worsening events defined as any of the following during the study period:\n\n1. PAH-related rehospitalization.\n2. Addition of PAH-targeted therapies (increased types\u002Fdose of PAH-targeted drugs or diuretics).\n3. ≥10% or ≥30-meter reduction in 6-Minute Walk Distance (6MWD) from baseline.\n4. Atrial septostomy.\n5. Need for lung transplantation.\n6. Cardiovascular death.","1 year",[14,18,20,22,25,27,30,32,34,36,38],{"measure":15,"description":16,"timeFrame":17},"WHO Functional Class changes from baseline",null,"6 months, 1, 2, 3, and 5 years",{"measure":19,"description":16,"timeFrame":17},"NT-proBNP\u002FBNP levels from baseline",{"measure":21,"description":16,"timeFrame":17},"6MWD changes from baseline",{"measure":23,"description":16,"timeFrame":24},"Incidence of pulmonary infections","Through study completion, an average of 5 years",{"measure":26,"description":16,"timeFrame":24},"All-cause death",{"measure":28,"description":29,"timeFrame":17},"Echocardiographic changes from baseline","Right atrial diameter (RAD)",{"measure":28,"description":31,"timeFrame":17},"Right ventricular end-diastolic diameter (RVDd)",{"measure":28,"description":33,"timeFrame":17},"Tricuspid annular plane systolic excursion (TAPSE)",{"measure":28,"description":35,"timeFrame":17},"Left ventricular ejection fraction (LVEF)",{"measure":28,"description":37,"timeFrame":17},"Left atrial diameter (LAD)",{"measure":28,"description":39,"timeFrame":17},"Left ventricular end-diastolic diameter (LVDd)",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":41,"timePerspective":42,"maskingInfo":16},"COHORT","PROSPECTIVE","Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":16,"otherNames":16},"DEVICE","Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China","PADN: Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55 # for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA. For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":16,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The First Affiliated Hospital with Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":58,"coordinates":59},"Point",[60,61],118.77778,32.06167,{"lat":61,"lon":60},[64],{"name":65,"role":66,"phone":67,"phoneExt":16,"email":68},"Shao-liang Chen, MD","CONTACT","+86 13605157029","chmengx@126.com",{"type":70,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100595988",false,"NCT07039604","Real-World Study of PADN for the Treatment of PAH","Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)","Inclusion Criteria:\n\n1. Diagnosed with PAH and received PADN procedure since March 2024.\n2. No contraindications to procedure.\n3. Able to provide informed consent and authorize use of health\u002Fresearch data.\n4. Compliant with treatment and follow-up requirements.\n\nExclusion Criteria:\n\nNone specified.","ALL",{"count":79,"type":80},200,"ESTIMATED","OBSERVATIONAL",[83,84],"Pulmonary Hypertension","Hypertension, Pulmonary Arterial","2025-06-17",{"date":87,"type":88},"2025-06-26","ACTUAL",{"date":90,"type":88},"2025-03-19",{"date":92,"type":80},"2028-12-30",{"name":5,"class":6},1]