Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System

Launched by SHANGHAI GOLDEN LEAF MEDTEC CO. LTD · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Netrod™ Renal Denervation (RDN) System, which uses a special device to help lower high blood pressure (hypertension) in adults who are not currently taking blood pressure medicines. The goal is to see if this treatment is safe and effective for people in Europe who have primary hypertension, meaning high blood pressure without a known secondary cause.

To join this study, participants need to be adults between 18 and 70 years old with blood pressure readings consistently above 150/90 mmHg but below 180/110 mmHg, and they should not be on any blood pressure medication. During the study, participants will undergo the renal denervation procedure, which involves using radiofrequency energy to treat nerves in the arteries of the kidneys, potentially helping to reduce blood pressure. The trial will include regular follow-up visits to monitor safety and blood pressure changes. However, not everyone can join—people with certain health conditions like kidney problems, heart issues, or those who are pregnant will not be eligible. This study is not yet recruiting, but if you meet the criteria and are interested, it could be an option to explore with your doctor.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Subject with age ≥18 years or minimum age as required by local regulations and ≤ 70 years old at time of consent
• • 2. Subject with hypertension who has an office BP of ≥ 150/90 mmHg and \< 180/110 mmHg (meet both SBP and DBP criteria) at Screening V2, and mean daytime ASBP ≥ 140 mmHg and \< 170 mmHg by 24-hour ABPM at Screening V2.
• • 3. Willing and able to provide informed consent
• • 4. Willing and able to comply with all study-specific visits, assessments, and requirements
• Exclusion Criteria:
• • 1. 1. Subject who is pregnant, nursing or planning to become pregnant during the course of the study
• • 2. 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 \< 3 mm or treatable segment length \< 20 mm)
• • 3. Subject with single-kidney or history of kidney transplant
• • 4. Subject with history of renal artery intervention (Percutaneous Transluminal Angioplasty \[PTA\] or stenting) or Renal Denervation (RDN)
• • 5. 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
• • 6. Subject with known secondary hypertension
• • 7. Subject with eGFR \<40 mL/min/l.73m²
• • 8. Subject with history of hospitalization for hypertensive emergency within past year
• • 9. Subject with type I diabetes mellitus
• • 10. Subject with primary pulmonary hypertension
• • 11. Subject with history of bleeding diathesis and haematological disorders or coagulopathy
• • 12. Subject with recent history of any embolism within 6 months
• • 13. Subject with history of coronary artery intervention, unstable angina or myocardial infarction
• • 14. Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
• • 15. Subject with history of abdominal aortic aneurysm
• • 16. Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia
• • 17. Subject with a history of ventricular fibrillation or ventricular tachycardia
• • 18. Subject known with serum Human Immunodeficiency Virus (HIV)-positive
• • 19. Subject who is allergic to contrast agents and not responding to preventive medication
• • 20. Subject with acute or severe systemic infections
• • 21. Subject with mental illness or any psychological problems that may interfere with participating in the study
• • 22. Subject with history of stroke or transient ischemic attack (TIA)
• • 23. Subject with malignant tumors or end-stage disease
• • 24. Subject with severe Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm
• • 25. Subject with severe heart valve stenosis or regurgitation
• • 26. Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)/ Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics)
• • 27. Subject with uncontrolled hyperthyroidism or hypothyroidism
• • 28. 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)
• • 29. Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea
• • 30. Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)/ Cardiac Resynchronization Therapy (CRT) device
• • 31. Subject with a history of major surgery or trauma within 30 days prior to enrolment
• • 32. Subject who has planned surgery or cardiovascular intervention within the next 12 months
• • 33. Subject who is participating in other drug or medical device clinical investigations
• • 34. Subject who is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.)