[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Golden Leaf MedTec Co. Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100635916","rdn-for-heart-failure-100635916",false,"NCT07558902","RDN for Heart Failure","Efficacy and Safety of Renal Denervation (RDN) for Heart Failure: A Single-Center, Prospective Cohort Study","Inclusion Criteria:\n\n1. Aged \\>18 years and ≤75 years with a clinical diagnosis of heart failure.\n2. Receiving optimized guideline-directed medical therapy (GDMT) for heart failure at stable doses for ≥4 weeks (diuretics stable for ≥2 weeks), with left ventricular ejection fraction (LVEF) ≤40% (HFrEF) or ≥50% (HFpEF).\n3. Symptomatic with exertional dyspnea or chest tightness; New York Heart Association (NYHA) functional class II or III.\n4. Serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level ≥500 pg\u002FmL at screening.\n5. Able to provide signed written informed consent personally, or having a legally authorized representative who can provide consent on behalf of the participant.\n\nExclusion Criteria:\n\n1. Pregnancy or planned pregnancy.\n2. Unsuitable renal artery anatomy for ablation on one or both sides (e.g., renal artery stenosis \\>50%, renal artery aneurysm, renal artery malformation, renal artery diameter \\\u003C3 mm, or treatable segment length \\\u003C20 mm).\n3. Presence of a single kidney, history of renal transplantation, or estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m².\n4. Acute heart failure episode or decompensation within 1 month prior to enrollment.\n5. Office systolic blood pressure (OSBP) ≤100 mmHg or 24-hour mean ambulatory systolic blood pressure (24hASBP) \\\u003C90 mmHg.\n6. Secondary hypertension (e.g., primary aldosteronism, pheochromocytoma\u002Fparaganglioma, Cushing's syndrome, thyroid disorders, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).\n7. History of allergy or hypersensitivity to contrast media.\n8. History of major surgery or trauma within 3 months prior to enrollment, history of acute coronary syndrome (ACS) within 6 months, or planned surgery or cardiovascular intervention within the next 6 months.\n9. Symptomatic orthostatic hypotension.\n10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or dilated cardiomyopathy.\n11. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c \\>6.5%).\n12. Primary pulmonary arterial hypertension.\n13. Significant bleeding diathesis or hematologic disorders (platelet count \\\u003C50×10⁹\u002FL, or coagulation abnormalities: activated partial thromboplastin time \\[APTT\\] or prothrombin time \\[PT\\] \\>3 times upper limit of normal \\[ULN\\], or international normalized ratio \\[INR\\] \\>1.5).\n14. History of systemic embolism within 6 months.\n15. History of stroke or transient ischemic attack (TIA) within 6 months.\n16. Severe peripheral vascular disease or abdominal aortic aneurysm.\n17. Significant (severe) valvular heart disease.\n18. Persistent or permanent atrial fibrillation; history of ventricular fibrillation or polymorphic ventricular tachycardia; or prior implantation of implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or permanent pacemaker.\n19. Severe hepatic impairment (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], or total bilirubin \\>3 times the upper limit of normal \\[ULN\\]).\n20. Concomitant serious medical conditions that would interfere with study participation or affect survival, such as malignancy or acquired immunodeficiency syndrome (AIDS).\n21. Acute or severe systemic infection.\n22. Conditions associated with chronic high-output states, such as severe anemia, advanced liver disease, hyperthyroidism, or arteriovenous fistula.\n23. Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center, prospective, single-arm clinical trial to evaluate the efficacy and safety of renal denervation (RDN) using a multi-channel radiofrequency ablation system in patients with symptomatic heart failure, including both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). The primary objective is to determine whether RDN can reduce serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from baseline to 6 months post-procedure, and improve functional exercise capacity as measured by the six-minute walk test (6MWT).\n\nApproximately 20 eligible participants will undergo the RDN procedure while continuing their optimal guideline-directed medical therapy for heart failure. Assessments will be performed at baseline (pre-procedure), and at 30 days, 3 months, and 6 months post-procedure. Key evaluations include NT-proBNP measurement, echocardiography, 6MWT, New York Heart Association (NYHA) functional class assessment, and safety monitoring for adverse events.\n\nThe study aims to provide preliminary clinical evidence on the effects of multi-channel RDN on cardiac biomarkers, functional status, and safety in heart failure patients, and to explore its potential as an adjunctive therapy for this population.",[27],"Heart Failure",[29],"RDN(renal denervation) treatment for Heart Failure","NOT_YET_RECRUITING","2026-04-27",{"date":33,"type":34},"2026-04-30","ACTUAL",{"date":36,"type":21},"2026-05-10",{"date":38,"type":21},"2027-09-13",{"name":40,"class":41},"Shanghai Golden Leaf MedTec Co. Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100597635","netrod-pilot-study-of-renal-denervation-with-netrodtm-sixelectrode-radiofrequency-rdn-system-100597635","NCT07061054","Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System","Safety and Efficacy of the CE-Marked NetrodTM Renal Denervation System in Treating Patients With Primary Hypertension in the Absence of Anti-hypertensive Medication: a Pilot Study With 20 Subjects","Inclusion criteria:\n\n1. Subject with age ≥18 years or minimum age as required by local regulations and ≤ 70 years old at time of consent\n2. Subject with hypertension who has an office BP of ≥ 150\u002F90 mmHg and \\\u003C 180\u002F110 mmHg (meet both SBP and DBP criteria) at Screening V2, and mean daytime ASBP ≥ 140 mmHg and \\\u003C 170 mmHg by 24-hour ABPM at Screening V2.\n3. Willing and able to provide informed consent\n4. Willing and able to comply with all study-specific visits, assessments, and requirements\n\nExclusion Criteria:\n\n1. 1\\. Subject who is pregnant, nursing or planning to become pregnant during the course of the study\n2. Subject with unilateral or bilateral renal artery that are not suitable for ablation procedure (renal artery stenosis more than 50%, renal aneurysm, renal artery abnormality, renal artery diameter \\\u003C 3 mm or treatable segment length \\\u003C 20 mm)\n3. Subject with single-kidney or history of kidney transplant\n4. Subject with history of renal artery intervention (Percutaneous Transluminal Angioplasty \\[PTA\\] or stenting) or Renal Denervation (RDN)\n5. Subject with any conditions that may affect the accuracy of blood pressure (BP) measurement: such as the diameter of the upper arm is too large for the cuff, or arrhythmia, etc\n6. Subject with known secondary hypertension\n7. Subject with eGFR \\\u003C40 mL\u002Fmin\u002Fl.73m²\n8. Subject with history of hospitalization for hypertensive emergency within past year\n9. Subject with type I diabetes mellitus\n10. Subject with primary pulmonary hypertension\n11. Subject with history of bleeding diathesis and haematological disorders or coagulopathy\n12. Subject with recent history of any embolism within 6 months\n13. Subject with history of coronary artery intervention, unstable angina or myocardial infarction\n14. Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)\n15. Subject with history of abdominal aortic aneurysm\n16. Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia\n17. Subject with a history of ventricular fibrillation or ventricular tachycardia\n18. Subject known with serum Human Immunodeficiency Virus (HIV)-positive\n19. Subject who is allergic to contrast agents and not responding to preventive medication\n20. Subject with acute or severe systemic infections\n21. Subject with mental illness or any psychological problems that may interfere with participating in the study\n22. Subject with history of stroke or transient ischemic attack (TIA)\n23. Subject with malignant tumors or end-stage disease\n24. Subject with severe Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm\n25. Subject with severe heart valve stenosis or regurgitation\n26. Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)\u002F Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics)\n27. Subject with uncontrolled hyperthyroidism or hypothyroidism\n28. Subject with severe electrolyte abnormalities, defined as values above and below the limits of normal (LN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 \\> Upper Limit of Normal (ULN)\n29. Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea\n30. Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)\u002F Cardiac Resynchronization Therapy (CRT) device\n31. Subject with a history of major surgery or trauma within 30 days prior to enrolment\n32. Subject who has planned surgery or cardiovascular intervention within the next 12 months\n33. Subject who is participating in other drug or medical device clinical investigations\n34. Subject who is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.)","70 Years",{"count":20,"type":21},[24],"This single-arm, non-randomized, open-label investigation aims to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive medication.",[55],"Uncontrolled Hypertension",[57,58,59,60,61,62,63,64,65,66],"Renal denervation (RDN)","Radiofrequency renal denervation","Sympathetic nervous system","Interventional therapy","Interventional cardiology","Device-based therapy","Renal artery denervation","Blood pressure","Resistant Hypertension","Refractory Hypertension","2026-02-09",{"date":69,"type":34},"2026-02-11",{"date":71,"type":21},"2026-04-01",{"date":73,"type":21},"2027-12-01",{"name":40,"class":41},""]