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

NCT06722651 | Withdrawn

• 1 other identifier: SGL-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Uncontrolled Hypertension

Keywords

Renal denervation (RDN); Radiofrequency renal denervation; Sympathetic nervous system; Interventional therapy; Interventional cardiology; Device-based therapy; Renal artery denervation; Blood pressure; Resistant Hypertension; Refractory Hypertension

Outcome Measures

Primary Outcomes (2)

• Mean daytime ambulatory systolic blood pressure

  Between-group difference in baseline adjusted change in mean daytime ambulatory systolic blood pressure (ASBP) at 3 months compared to baseline measured by 24 hours ambulatory blood pressure monitoring (ABPM) (RDN vs sham vs open-label).

  From baseline at Screening Visit 2 to Month 3 post-procedure

• Periprocedural major adverse event (MAE) rate

  Periprocedural major adverse event (MAE) rate, defined as a composite of the following events at 30 days post procedure: * All-cause mortality * End-stage renal disease (ESRD) defined as stage 5 CKD (eGFR \< 15 mL/min/l.73m²) or hemodialysis * Significant embolic event resulting in end-organ damage * Renal artery perforation or dissection requiring intervention * Major vascular complications requiring medical or surgical intervention * Hospitalization for hypertensive crisis (unless clearly demonstrated to be associated with non-adherence with antihypertensive medications in the subjects on escape medication) * New renal artery stenosis \> 70% (must be confirmed by angiography)

  At 30 days post-procedure

Secondary Outcomes (9)

• Office blood pressure (BP) and home BP

  From baseline at Screening Visit 2 to Month 1, 3, 12, 24 and 36 post-procedure

• Mean ambulatory BP including 24-hour ASBP and ADBP, daytime and nighttime SBP and DBP

  From baseline at Screening Visit 2 to Month 1, 3, 12, 24 and 36 post-procedure

• Percentage of patients with office systolic BP (SBP) within the target range (SBP <140 mmHg)

  At Month 3, 12, 24 and 36 post-procedure

• Percentage of patients with office systolic blood pressure (SBP) within the target range (SBP <130 mmHg)

  At Month 3, 12, 24 and 36 post-procedure

• Percentage of patients with mean ambulatory systolic blood pressure (ASBP) within the target range (SBP <130 mmHg)

  At Month 3, 12, 24 and 36 post-procedure

Study Arms (3)

Renal Denervation

EXPERIMENTAL

Renal angiogram and Renal Denervation procedure

Device: Netrod™ six-electrode radiofrequency renal denervation system

Sham Control group

SHAM COMPARATOR

Renal angiogram followed by Sham procedure

Device: Sham Procedure

Open-label Control group

NO INTERVENTION

The patient will not undergo either the renal angiogram or the RDN procedure.

Interventions

Netrod™ six-electrode radiofrequency renal denervation system DEVICE

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.

Renal Denervation

Sham Procedure DEVICE

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

Sham Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with age ≥18 years or minimum age as required by local regulations and ≤80 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 V3 and mean daytime ASBP ≥140 mmHg and \<170 mmHg by 24-hour ABPM at Screening V3
• Subject or his/her legal representative must sign an IEC/REB-approved ICF for the study
• Subject is willing to discontinue current antihypertensive medications at Screening V1 through the 3-month follow-up visit

You may not qualify if:

• \. 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 (PTA or stenting) or RDN
• Subject with any conditions that may affect the accuracy of blood pressure 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

Sponsors & Collaborators

• Shanghai Golden Leaf MedTec Co. Ltd: lead
• European Cardiovascular Research Center: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland, Switzerland

Location

Related Publications (1)

• Li Y, Gao F, Ren C, Ma G, Bu P, Fu G, Chen H, Han Z, Li Y, Li J, Ma X, Hao L, Chen Y, Chen M, Chen X, Liu X, Jiang J, Yu J, Li N, Ma X, Yang B, Cong H, Wang X, Fan Q, Lv S, Wu D, Dai Q, Qiu F, Cai H, Zhou YJ. The Netrod six-electrode radiofrequency renal denervation system for uncontrolled hypertension: a sham-controlled trial. Eur Heart J. 2024 Nov 21;45(44):4761-4764. doi: 10.1093/eurheartj/ehae703. No abstract available.

  PMID: 39431289 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Felix Mahfoud, Prof. Dr.

  Department of Cardiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

• Andrew Sharp, Prof.

  The Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either the RDN procedure, sham procedure, or open-label control (where patients do not receive any procedure and are off medication until primary endpoint measurement). After primary endpoint measurements at Month 3, patients in the sham and open-label control groups will have the option to receive the RDN procedure, referred to as "crossover patients."

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 9, 2024
• Study Start: August 30, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)