Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-02 @ 10:06 AM
Study NCT ID:
NCT07039604
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study of PADN for the Treatment of PAH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical worsening', 'timeFrame': '1 year', 'description': '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/dose 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.'}], 'secondaryOutcomes': [{'measure': 'WHO Functional Class changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years'}, {'measure': 'NT-proBNP/BNP levels from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years'}, {'measure': '6MWD changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years'}, {'measure': 'Incidence of pulmonary infections', 'timeFrame': 'Through study completion, an average of 5 years'}, {'measure': 'All-cause death', 'timeFrame': 'Through study completion, an average of 5 years'}, {'measure': 'Echocardiographic changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years', 'description': 'Right atrial diameter (RAD)'}, {'measure': 'Echocardiographic changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years', 'description': 'Right ventricular end-diastolic diameter (RVDd)'}, {'measure': 'Echocardiographic changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years', 'description': 'Tricuspid annular plane systolic excursion (TAPSE)'}, {'measure': 'Echocardiographic changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years', 'description': 'Left ventricular ejection fraction (LVEF)'}, {'measure': 'Echocardiographic changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years', 'description': 'Left atrial diameter (LAD)'}, {'measure': 'Echocardiographic changes from baseline', 'timeFrame': '6 months, 1, 2, 3, and 5 years', 'description': 'Left ventricular end-diastolic diameter (LVDd)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Hypertension, Pulmonary Arterial']}, 'descriptionModule': {'briefSummary': 'Real-World Study of PADN for the Treatment of PAH'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.', 'eligibilityCriteria': '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/research data.\n4. Compliant with treatment and follow-up requirements.\n\nExclusion Criteria:\n\nNone specified.'}, 'identificationModule': {'nctId': 'NCT07039604', 'briefTitle': 'Real-World Study of PADN for the Treatment of PAH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulnovo Medical (Wuxi) Co., Ltd.'}, 'officialTitle': 'Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': 'PADN-PMS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China', 'type': 'DEVICE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shao-liang Chen, MD', 'role': 'CONTACT', 'email': 'chmengx@126.com', 'phone': '+86 13605157029'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulnovo Medical (Wuxi) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}