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EuroNetrod HTN OFF-Med Study of Renal Denervation With NetrodTM Six-electrode Radiofrequency RDN System

NCT06722651 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-31

No results posted yet for this study

Summary

This randomized controlled investigation aims to evaluate the efficacy and safety of the Netrod™ RDN system in patients with uncontrolled primary hypertension in the absence of antihypertensive medication, comparing the outcomes between renal denervation, sham procedure, and open-label control groups.

Conditions

Interventions

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.

DEVICE

Sham Procedure

Patients will be remained on the catheterization table for at least 20 min prior to sheath removal.

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Shanghai Golden Leaf MedTec Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Felix Mahfoud, Prof. Dr. · Department of Cardiology, University Hospital Basel

  • Andrew Sharp, Prof. · The Mater Misericordiae University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2028-11-30
Completion
2031-08-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06722651 on ClinicalTrials.gov