Uncontrolled HypertensionNCT07061054
Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System
A study testing Netrod™ six-electrode radiofrequency renal denervation system in people with Uncontrolled Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Netrod™ six-electrode radiofrequency renal denervation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. 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
Show all 34Show fewer
- 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
- Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia
- Subject with a history of ventricular fibrillation or ventricular tachycardia
- Subject known with serum Human Immunodeficiency Virus (HIV)-positive
- Subject who is allergic to contrast agents and not responding to preventive medication
- Subject with acute or severe systemic infections
- Subject with mental illness or any psychological problems that may interfere with participating in the study
- Subject with history of stroke or transient ischemic attack (TIA)
- Subject with malignant tumors or end-stage disease
- Subject with severe Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm
- Subject with severe heart valve stenosis or regurgitation
- Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)/ Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics)
- Subject with uncontrolled hyperthyroidism or hypothyroidism
- Subject with severe electrolyte abnormalities, defined as values above and below the limits of normal (LN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 > Upper Limit of Normal (ULN)
- Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea
- Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)/ Cardiac Resynchronization Therapy (CRT) device
- Subject with a history of major surgery or trauma within 30 days prior to enrolment
- Subject who has planned surgery or cardiovascular intervention within the next 12 months
- Subject who is participating in other drug or medical device clinical investigations
- Subject who is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Barcelona Clinic Hospital
Barcelona, Catalonia, 08036
Pablo Iglesias García, Msc, RN, +34 93 227 54 00, piglesia@recerca.clinic.cat
Miguel Camafort, M.D. Ph.D
About this study
Official title: 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
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.
Read the 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
- Being tested
- Netrod™ six-electrode radiofrequency renal denervation system
- 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
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netrod™ six-electrode radiofrequency renal denervation systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Renal angiogram and Renal Denervation procedure Receives: Device: Netrod™ six-electrode radiofrequency renal denervation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: From baseline to 3 months post index procedure
Secondary outcomes (8)
Incidence of the safety events
Incidence of the following events:
- All-cause mortality
- 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 Cerebrovascular Accident (CVA)
- Renal artery reintervention
- New renal artery stenosis > 70% confirmed by angiography
- Hospitalization for hypertensive crisis not related to confirmed non-adherence of anti-hypertensive medications
- Hospitalization for major cardiovascular- or hemodynamic-related events (such as heart failure or atrial fibrillation)
Measured: At 3, 6 and 12 months post procedure
Incidence of serious adverse events (SAEs) related to the investigational device
The incident of serious adverse events (SAEs) related to the investigational device within 12 months post index procedure.
Measured: From day 0 (procedure) to 12 months post index procedure
Incidence of device deficiency
Incidence of device deficiency
Measured: At Visit 3, day 0 (procedure)
Mean ambulatory BP
Changes from baseline in mean ambulatory BP including 24-hour ambulatory blood pressure, including ASBP and Ambulatory Diastolic Blood Pressure (ADBP), daytime and nighttime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured by ABPM at 3- and 12-month post index procedure (except 24-hour mean daytime ASBP at 3-month post index procedure, which is already included in the primary endpoint)
Measured: From baseline at Visit 2 to 3- and 12-month post index procedure
Office blood pressure (OBP)
Changes from baseline in office blood pressure (OBP) at 1-, 3-, 6- and 12-month post index procedure
Measured: From baseline at Visit 2 to 1-, 3-, 6- and 12-month post index procedure
Percentage of patients with office systolic blood pressure within target range
Percentage of patients with office systolic blood pressure (OSBP) within target range (SBP <140 mmHg and SBP <130 mmHg) at 3-, 6- and 12-month post index procedure
Measured: At 3-, 6- and 12-month post index procedure
Percentage of patients with mean ASBP within the target range
Percentage of patients with mean ASBP within the target range (ASBP <130 mmHg) at 3- and 12-month post index procedure
Measured: At 3- and 12-month post index procedure
Proportion of OSBP decreased by ≥ 5, 10, 15 and 20 mmHg
- The proportion of OSBP decreased by ≥ 5, 10, 15 and 20 mmHg at 3-month post index procedure
Measured: At 3-month post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061054
- Sponsor's protocol ID
- Netrod OFF-MED Pilot
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07061054
- Acronym / sponsor ID
- Netrod OFF-MED Pilot
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Netrod™ six-electrode radiofrequency renal denervation systemRenal angiogram and Renal Denervation procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (34 listed)
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netrod™ six-electrode radiofrequency renal denervation systemNetrod™ 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 | Renal Denervation |
Primary outcome
Incidence of periprocedure major adverse event (MAE)
Time frame: Through 30 days post index procedure
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)
Mean daytime ambulatory systolic blood pressure (ASBP)
Time frame: From baseline to 3 months post index procedure
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
8 secondary outcomes
Incidence of the safety events
Time frame: At 3, 6 and 12 months post procedure
Incidence of serious adverse events (SAEs) related to the investigational device
Time frame: From day 0 (procedure) to 12 months post index procedure
Incidence of device deficiency
Time frame: At Visit 3, day 0 (procedure)
Mean ambulatory BP
Time frame: From baseline at Visit 2 to 3- and 12-month post index procedure
Office blood pressure (OBP)
Time frame: From baseline at Visit 2 to 1-, 3-, 6- and 12-month post index procedure
Percentage of patients with office systolic blood pressure within target range
Time frame: At 3-, 6- and 12-month post index procedure
Percentage of patients with mean ASBP within the target range
Time frame: At 3- and 12-month post index procedure
Proportion of OSBP decreased by ≥ 5, 10, 15 and 20 mmHg
Time frame: At 3-month post index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 39431289Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Netrod™ six-electrode radiofrequency renal denervation system in people with Uncontrolled Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sky Wang (+8618611405679, xiaobei.wang@brattea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of periprocedure major adverse event (MAE) (time frame: Through 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07061054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.