[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644352":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":53,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Xiamen Cardiovascular Hospital, Xiamen University","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"PADN group (receiving PADN plus standard medical therapy)","EXPERIMENTAL",[12],"Device: Percutaneous Pulmonary Artery Denervation (PADN)",{"label":14,"type":15,"description":14,"interventionNames":16},"Control group (receiving standard medical therapy alone)","PLACEBO_COMPARATOR",[17],"Drug: Control group (receiving standard medical therapy alone)",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Percutaneous Pulmonary Artery Denervation (PADN)","\\*\\*PADN Procedure Steps:\\*\\*\n\n1. Non-Selective Pulmonary Artery Angiography\n2. PADN Ablation Target Selection\n3. Hemodynamic Assessment\n4. Establishment of the PADN® RF Catheter Delivery Rail\n5. PADN® RF Catheter Delivery\n6. Performance of the PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A, B, and C. . Temperature-controlled mode is recommended for radiofrequency ablation, with the ablation temperature set to 50°C and the total ablation time set to 150 seconds. The pulmonary artery radiofrequency ablation generator will automatically start calculating the effective ablation time (ET) once the ablation temperature reaches 45°C. Ablation at each target point is considered effective when the ET reaches at least 120 seconds.\n7. Completion of the PADN",[9],null,{"type":26,"name":14,"description":14,"armGroupLabels":27,"otherNames":24},"DRUG",[14],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Xiang CHEN, Dr","CONTACT","+8618033997788","seanchenx@126.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Structural Heart Disease Unit, Xiamen Cardiovacular Hospital","RECRUITING","Xiamen","Fujian","361000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],118.08187,24.47979,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":24,"email":33},"Xiang Chen","18033997788",{"type":54,"investigatorFullName":51,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100644352","early-phase-1-percutaneous-pulmonary-artery-denervation-padn-for-the-treatment-of-pulmonary-hypertension-after-transcatheter-mitral-valve-edge-to-edge-repair-m-teer-a-prospective-cohort-study-100644352",false,"NCT07662655","Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study","Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years;\n2. Diagnosed with pulmonary hypertension (defined as mPAP \\>20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;\n3. No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);\n4. Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;\n5. Willing to comply with the treatment and follow-up schedule required by the protocol\n\nExclusion Criteria:\n\n1. Cardiac index (CI) \\\u003C 1.5 L\u002Fmin\u002Fm²;\n2. Severe renal insufficiency (creatinine clearance rate (CrCL) \\\u003C 30 mL\u002Fmin);\n3. Left ventricular ejection fraction (EF) \\\u003C30% on echocardiography;\n4. Severe hematological disease or severe bleeding tendency (platelet count \\\u003C10×10⁹\u002FL; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);\n5. Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;\n6. Acute systemic infectious disease;\n7. Poor general condition due to various systemic diseases;\n8. Pulmonary veno-occlusive disease;\n9. Cachexia;\n10. Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;\n11. Anticipated to undergo other surgical or interventional procedures within 6 months;\n12. Life expectancy \\\u003C12 months;\n13. Allergy to the drugs or metal materials used in the study;\n14. Women who are breastfeeding, pregnant, or planning to become pregnant within one year;\n15. Participation in another drug or medical device clinical trial within 3 months prior to screening;\n16. Any condition deemed unsuitable for participation in this clinical trial by the investigator. \\|","ALL","18 Years","80 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"EARLY_PHASE1","this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making",[73,74],"Pulmonary Hypertension","Pulmonary Hypertension Associated With HFpEF","2026-06-17",{"date":77,"type":78},"2026-06-23","ACTUAL",{"date":80,"type":78},"2026-06-06",{"date":82,"type":67},"2028-08-31",{"name":5,"class":6},1]