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WithdrawnNCT06722651EuroNetrodUpdated Jul 31, 2025

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

An interventional study of Netrod™ six-electrode radiofrequency renal denervation system and Sham Procedure in Uncontrolled Hypertension, sponsored by Shanghai Golden Leaf MedTec Co. Ltd. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Shanghai Golden Leaf MedTec Co. Ltd · Not applicable, Interventional, and Treatment

Why this study was withdrawn
This decision aims to concentrate resources on accelerating the development of the next generation of the NetrodTM RDN System.This reflects a broader strategy to advancing more effective solutions for physicians and patients.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the detailed description

This is a prospective, multi-center, blinded, three-arm randomized controlled study to demonstrate the effectiveness and safety of the Netrod™ RDN system for treating treating patients with uncontrolled primary hypertension in the absence of antihypertensive medications. This clinical investigation will enroll 260 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 three weeks, and those who continue to meet the eligibility requirements will be randomized in a 2:1:1 ratio to one of three groups: renal denervation (RDN), a sham procedure (renal artery angiogram only), or an open-label group (not undergoing the renal angiogram).

All subjects randomized to either the treatment or sham procedure groups will be evaluated at hospital discharge. All subjects will be evaluated at 1 and 3 months post-procedure. Additionally, patients who undergo the RDN procedure will also be evaluated at 12, 24, and 36 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.

Patients in the RDN and sham-control groups, as well as all clinical follow-up assessors, will be blinded to the treatment allocation. 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 periprocedural major adverse event (MAE) rate at 30 days post-procedure.

Subjects enrolled in the sham and open-label control groups may cross over to RDN at three months. Those who cross over will restart the follow-up schedule post-RDN procedure.

02

Conditions studied

  • Uncontrolled Hypertension

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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
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Shanghai Golden Leaf MedTec Co. Ltd is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject with age ≥18 years or minimum age as required by local regulations and ≤80 years old at time of consent
  2. 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
  3. Subject or his/her legal representative must sign an IEC/REB-approved ICF for the study
  4. Subject is willing to discontinue current antihypertensive medications at Screening V1 through the 3-month follow-up visit

Exclusion criteria

Exclusion Criteria:

  1. 1. Subject who is pregnant, nursing or planning to become pregnant during the course of the study
  2. 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)
  3. Subject with single-kidney or history of kidney transplant
  4. Subject with history of renal artery intervention (PTA or stenting) or RDN
  5. 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.
  6. Subject with known secondary hypertension
  7. Subject with eGFR \<40 mL/min/l.73m²
  8. Subject with history of hospitalization for hypertensive emergency within past year
  9. Subject with type I diabetes mellitus
  10. Subject with primary pulmonary hypertension
  11. Subject with history of bleeding diathesis and haematological disorders or coagulopathy
  12. Subject with recent history of any embolism within 6 months
  13. Subject with history of coronary artery intervention, unstable angina or myocardial infarction
  14. Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
  15. Subject with history of abdominal aortic aneurysm
  16. Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rhythm control medication for arrhythmia
  17. Subject with a history of ventricular fibrillation or ventricular tachycardia
  18. Subject known with serum HIV-positive
  19. Subject who is allergic to contrast agents and not responding to preventive medication
  20. Subject with acute or severe systemic infections
  21. Subject with mental illness or any psychological problems that may interfere with participating in the study
  22. Subject with history of stroke or transient ischemic attack (TIA)
  23. Subject with malignant tumors or end-stage disease
  24. Subject with severe PAD along the access path to renal arteries, including abdominal aneurysm
  25. Subject with severe heart valve stenosis or regurgitation
  26. Subject with heart failure requiring medications (i.e. ACE/ARB, SGTL2i, diuretics).
  27. Subject with uncontrolled hyperthyroidism or hypothyroidism
  28. Subject with severe electrolyte abnormalities, defined as values above and below the limits of normal (ULN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 > ULN
  29. Subject who requires mechanical ventilation other than CPAP for sleep apnea
  30. Subject with a implanted pacemaker or ICD/CRT device
  31. Subject with a history of major surgery or trauma within 30 days prior to enrolment
  32. Subject who has planned surgery or cardiovascular intervention within the next 12 months
  33. Subject who is participating in other drug or medical device clinical investigations
  34. Subject who has known drug or alcohol dependence, difficulty to understand the clinical investigation protocol, inability/unwillingness to follow the clinical investigation protocol
  35. Subject who is unsuitable to participate in this study in the opinion of investigators
  36. Subjects who are incapacitated or unable to provide informed consent due to cognitive impairment, mental illness, or other conditions that affect their decision-making capacity.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Renal Denervation

    Renal angiogram and Renal Denervation procedure

    Device: Netrod™ six-electrode radiofrequency renal denervation system

  • Sham comparator
    Sham Control group

    Renal angiogram followed by Sham procedure

    Device: Sham Procedure

  • No intervention
    Open-label Control group

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

Interventions

  • DeviceNetrod™ 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.

  • DeviceSham Procedure

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

06

What researchers measure

Primary outcomes

  1. 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).

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

  2. 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)

    Time frame: At 30 days post-procedure

Secondary outcomes

  1. Office blood pressure (BP) and home BP

    Changes from baseline in office blood pressure (BP) and home BP at 1- and 3-month post procedure for all enrolled subjects, and 12-, 24- and 36-month post procedure for the subjects who underwent RDN

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

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

    Changes from baseline in mean ambulatory BP including 24-hour ASBP and ADBP, daytime and nighttime SBP and DBP measured by 24-hour ABPM at 1-, 3-month for all enrolled subjects, and 12-, 24- and 36-month for the subjects who underwent RDN.

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

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

    Percentage of patients with office systolic BP (SBP) within the target range (SBP \<140 mmHg) at 3-month post procedure for all enrolled subjects, and 12-, 24- and 36-month post procedure for the subjects who underwent RDN

    Time frame: At Month 3, 12, 24 and 36 post-procedure

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

    Percentage of patients with office systolic blood pressure (SBP) within the target range (SBP \<130 mmHg) at 3-month post procedure for all enrolled subjects, and 12-, 24- and 36-month post procedure for the subjects who underwent RDN

    Time frame: At Month 3, 12, 24 and 36 post-procedure

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

    Percentage of patients with mean ambulatory systolic blood pressure (ASBP) within the target range (SBP \<130 mmHg) at 3-month post procedure for all enrolled subjects, and 12-, 24- and 36-month post procedure for the subjects who underwent RDN

    Time frame: At Month 3, 12, 24 and 36 post-procedure

  6. The proportion of ambulatory SBP decreased by 5 and 10 mmHg

    The proportion of ambulatory SBP decreased by 5 and 10 mmHg at 3-month post procedure

    Time frame: At Month 3 post-procedure

  7. Safety event rates

    The following safety event rates to 3-month post procedure for all enrolled subjects, and the following event rates at 12-, 24- and 36-month post procedure for the subjects who underwent RDN procedure: * All-cause mortality * End-stage renal disease (ESRD) defined as stage 5 CKD (eGFR \< 15 mL/min/l.73m²) * ≥50% decline in eGFR or \>50% increase in serum creatinine from baseline * New myocardial infarction or acute coronary syndrome (ACS) * New stroke or CVA * Renal artery reintervention * New renal artery stenosis \> 70% confirmed by angiography * Hospitalization for hypertensive crisis not related to confirmed non-adherence of antihypertensive medications * Hospitalization for major cardiovascular- or hemodynamic-related events (such as heart failure or atrial fibrillation)

    Time frame: At Month 3 post-procedure

  8. Device deficiency rates

    Device deficiency rates

    Time frame: At Visit 4, day 0 (procedure)

  9. Quality of life changes

    Quality of life changes at 12 months and annually through 3 years post index procedure

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

07

Study locations

1 site
  • University Hospital Basel
    Basel, Canton of Basel-City Switzerland, Switzerland
08

References and documents

Publications

  • 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. PubMed 39431289 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06722651
Lead sponsor
Shanghai Golden Leaf MedTec Co. Ltd
Collaborators
European Cardiovascular Research Center
Responsible party
Sponsor
First posted
Dec 9, 2024
Start date
Aug 30, 2025 (estimated)
Primary completion
Nov 2028 (estimated)
Completion
Aug 2031 (estimated)
Last update
Jul 31, 2025

Study contacts

Felix Mahfoud, Prof. Dr.
principal investigator · Department of Cardiology, University Hospital Basel
Andrew Sharp, Prof.
principal investigator · The Mater Misericordiae University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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