Tests a device to treat high blood pressure without medication

Trial details

Who runs it

Shanghai Golden Leaf MedTec Co. Ltd

Trial code

NCT07061054

Record updated

11 February 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Subject with age ≥18 years or minimum age as required by local regulations and ≤ 70 years old at time of consent; 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; Willing and able to provide informed consent; Willing and able to comply with all study-specific visits, assessments, and requirements.

Exclusion: Subject with a history of major surgery or trauma within 30 days prior to enrolment; Subject who has planned surgery or cardiovascular intervention within the next 12 months; Subject who is participating in other drug or medical device clinical investigations; Subject with single-kidney or history of kidney transplant; Subject with history of renal artery intervention (Percutaneous Transluminal Angioplasty [PTA] or stenting) or Renal Denervation (RDN); 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; Subject with known secondary hypertension; Subject with history of hospitalization for hypertensive emergency within past year; Subject with type I diabetes mellitus; Subject with primary pulmonary hypertension; Subject with history of bleeding diathesis and haematological disorders or coagulopathy; Subject with recent history of any embolism within 6 months; Subject with history of coronary artery intervention, unstable angina or myocardial infarction; Subject with history of abdominal aortic aneurysm; Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia; Subject with a history of ventricular fibrillation or ventricular tachycardia; Subject who is allergic to contrast agents and not responding to preventive medication; Subject with acute or severe systemic infections; Subject with mental illness or any psychological problems that may interfere with participating in the study; Subject with history of stroke or transient ischemic attack (TIA); Subject with malignant tumors or end-stage disease; Subject with severe Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm; Subject with severe heart valve stenosis or regurgitation; Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)/ Cardiac Resynchronization Therapy (CRT) device; Subject who is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.); Subject with eGFR <40 mL/min/l.73m²; Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates); Subject known with serum Human Immunodeficiency Virus (HIV)-positive; Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)/ Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics); 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); 1. Subject who is pregnant, nursing or planning to become pregnant during the course of the study; 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); Subject with uncontrolled hyperthyroidism or hypothyroidism; Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea.

ClinicalTrials.gov NCT07061054