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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Golden Leaf MedTec Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, single-arm, non-randomized, open-label, multi-center study 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. This clinical investigation aims to enroll 20 patients in Europe. Patients with uncontrolled primary hypertension (office BP ≥150/90 mmHg and \<180/110 mmHg) who are willing to discontinue antihypertensive medications will be screened after providing informed consent. All eligible patients will undergo a medication washout period of at least 21 days, and those who continue to meet the eligibility requirements will undergo the RDN procedure using the Netrod™ RDN System. Subjects will be evaluated at hospital discharge and at 1, 3, 6, and 12 months post-procedure. All subjects will remain off antihypertensive medications until the primary endpoint is assessed at the 3-month follow-up visit, after which antihypertensive medications may be reintroduced. The primary efficacy endpoint is the change in daytime ambulatory systolic blood pressure (ASBP) from baseline at three months post-procedure. The primary safety endpoint is the incidence of periprocedural major adverse event (MAE) rate through 30 days post index procedure.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DEVICE	Netrod™ six-electrode radiofrequency renal denervation system	Netrod™ renal denervation (RDN) system, which is indicated for the treatment of uncontrolled hypertension. It consists of the following two components: Netrod™ Six-Electrode Basket Radiofrequency Renal Denervation Catheter and Netrod™ Renal Denervation Radiofrequency Generator. The catheter's electrodes deploy into a self adaptive basket structure, optimizing contact with the vessel wall for effective ablation.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2025-07-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Spain