[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pulnovo Medical (Wuxi) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":13,"conditions":21,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100595988","real-world-study-of-padn-for-the-treatment-of-pah-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":18,"type":19},200,"ESTIMATED","OBSERVATIONAL",[22,23],"Pulmonary Hypertension","Hypertension, Pulmonary Arterial","RECRUITING","2025-06-17",{"date":27,"type":28},"2025-06-26","ACTUAL",{"date":30,"type":28},"2025-03-19",{"date":32,"type":19},"2028-12-30",{"name":34,"class":35},"Pulnovo Medical (Wuxi) Co., Ltd.","INDUSTRY",1,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":61,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":36},"100502643","phase-3-a-trial-to-evaluate-the-safety-and-efficacy-of-pulmonary-artery-denervation-for-the-treatment-of-pulmonary-hypertension-associated-with-left-heart-failure-100502643","NCT05824923","A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure","A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure","PADN-HF-PH","Inclusion Criteria:\n\n1. Age ≥18, ≤75 years old;\n2. Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;\n3. Clinically stable defined by\n\n   1. No intravenous diuretics, inotropes or vasodilators for at least 1 month, and\n   2. Systolic blood pressure (SBP) ≥ 100 and \\\u003C 160 mmHg and resting heart rate (HR) ≥50 and \\\u003C100 bpm (\\\u003C110 bpm for atrial fibrillation) on the day of the procedure\n4. New York Heart Association (NYHA) class II-IVa;\n5. 6MWD ≥ 100 m and \\\u003C 450 m;\n6. NT-proBNP \\> 125 pg\u002FmL (BNP \\> 35 pg\u002FmL);\n7. Hemodynamic indicators (RHC) :\n\n   1. Mean pulmonary arterial pressure (mPAP) \\> 20 mmHg\n   2. Pulmonary capillary wedge pressure (PCWP) \\>15 mmHg\n8. Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.\n\nExclusion Criteria:\n\n1. Any of the following:\n\n   1. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or\n   2. Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or\n   3. Untreated congenital heart disease; or\n   4. Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or\n   5. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or\n   6. Anticipated to undergo ablation of atrial fibrillation within 6 months; or\n   7. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or\n   8. Listing for heart\u002Fheart-lung transplantation or anticipated to implant a ventricular assist device (VAD)\n2. Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;\n3. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;\n4. Anticipated to undergo any surgery within 6 months;\n5. The cardiac index (CI) of RHC \\\u003C 1.5L\u002Fmin\u002Fm²;\n6. Severe renal insufficiency (eGFR \\\u003C30mL\u002Fmin\u002F1.73m² by MDRD formula);\n7. Severe liver insufficiency (Child-Pugh classification C);\n8. Platelet count \\\u003C 50 × 10\\^9\u002FL;\n9. Life expectancy \\\u003C1 year;\n10. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;\n11. Active infection requiring oral or intravenous antibiotics;\n12. Body mass index (BMI) \\>40 kg\u002Fm²;\n13. Pregnant or lactating women, or plan to pregnant in one year;\n14. Participated in other clinical trials within 3 months prior to signing the informed consent;\n15. Any other circumstances that investigators deem inappropriate to participate in this trial.","18 Years","75 Years",{"count":48,"type":19},264,"INTERVENTIONAL",[51],"PHASE3","It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.",[22,54,55,56,57,58,59,60],"Heart Failure With Reduced Ejection Fraction","Hypertension","Vascular Diseases","Cardiovascular Diseases","Heart Failure","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mid Range Ejection Fraction",[62,63,58,64,65],"Pulmonary Artery Denervation","Pulmonary Hypertension Due to Left Heart Disease","pulmonary hypertension","left heart failure","2024-09-18",{"date":68,"type":28},"2024-09-20",{"date":70,"type":28},"2023-08-14",{"date":72,"type":19},"2027-02",{"name":34,"class":35},""]