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

NCT07061054 | Not Yet Recruiting

• 1 other identifier: Netrod OFF-MED Pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

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)

• Incidence of periprocedure major adverse event (MAE)

  Incidence of periprocedure major adverse event (MAE), defined as a composite of the following events through 30 days post index procedure (except for new renal artery stenosis): * All-cause mortality * End-stage renal disease (ESRD) defined as stage 5 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate (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)

  Through 30 days post index procedure

• Mean daytime ambulatory systolic blood pressure (ASBP)

  Changes from baseline in mean daytime ambulatory systolic blood pressure (ASBP) by 24-hour ambulatory blood pressure monitoring (ABPM) at 3 months post index procedure

  From baseline to 3 months post index procedure

Secondary Outcomes (8)

• Incidence of the safety events

  At 3, 6 and 12 months post procedure

• Incidence of serious adverse events (SAEs) related to the investigational device

  From day 0 (procedure) to 12 months post index procedure

• Incidence of device deficiency

  At Visit 3, day 0 (procedure)

• Mean ambulatory BP

  From baseline at Visit 2 to 3- and 12-month post index procedure

• Office blood pressure (OBP)

  From baseline at Visit 2 to 1-, 3-, 6- and 12-month post index procedure

Study Arms (1)

Renal Denervation

EXPERIMENTAL

Renal angiogram and Renal Denervation procedure

Device: Netrod™ six-electrode radiofrequency renal denervation system

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

Eligibility Criteria

• Age: 18 Years - 70 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 ≤ 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:

• \. 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

Sponsors & Collaborators

• Shanghai Golden Leaf MedTec Co. Ltd: lead
• North American Science Associates Ltd.: collaborator

Study Sites (1)

Barcelona Clinic Hospital

Barcelona, Catalonia, 08036, Spain

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

Central Study Contacts

Sky Wang

CONTACT

+8618611405679; xiaobei.wang@brattea.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)