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

Starting soon · Not applicable

Conditions studied: Uncontrolled Hypertension

In brief

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.

Key facts

Study ID: NCT07061054
Run by: Shanghai Golden Leaf MedTec Co. Ltd
People needed: 20
Starts: 2026-04-01
Expected to finish: 2027-12-01
Last updated by the study team: 2026-02-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 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 eGFR <40 mL/min/l.73m²
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 stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
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 known with serum Human Immunodeficiency Virus (HIV)-positive
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

Where it is running

Barcelona Clinic Hospital — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.