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HypertensionNCT07130955

A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease

A study testing Six-channel RF Renal Denervation System in people with Hypertension and CKD - Chronic Kidney Disease, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Prospective, Multi-Center, Randomized, Parallel-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radiofrequency（RF) renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypertension, CKD - Chronic Kidney Disease
What is being tested?
Six-channel RF Renal Denervation System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
236 participants
Where
1 siteChina
Study dates
8 Aug 2025to 30 Sep 2030
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18 to 65 years, inclusive, at the time of consent;
  • Hypertensive subjects who have been taking 2 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure still ≥150 mmHg and <180 mmHg, and 24-hour ambulatory mean systolic blood pressure (24h SBP) ≥135 mmHg and <170 mmHg; or who have been taking ≥3 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure ≥140 mmHg and <180 mmHg, and 24h SBP ≥130 mmHg and <170 mmHg;
  • Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m² and <60 mL/min/1.73m²;
  • The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.

Who cannot join

  • Pregnant or breastfeeding, or planning pregnancy during the study.
  • Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter <3 mm, or treatable segment length <20 mm).
  • Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis.
  • Prior renal artery intervention or prior renal denervation.
  • Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
  • Allergic to contrast agents.
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  • Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.
  • Orthostatic hypotension.
  • Type 1 diabetes mellitus.
  • Primary pulmonary arterial hypertension.
  • History of bleeding diathesis and haematological disorders or coagulopathy
  • History of thromboembolic event within 6 months.
  • History of stroke or transient ischemic attack (TIA) within 6 months.
  • Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
  • Severe valvular heart disease or anticipated need for surgical valve replacement during the study period.
  • NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
  • History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
  • Acute kidney injury (AKI) within 4 weeks before enrollment or acute kidney disease ，AKI: ≥50% increase in serum creatinine within 7 days, or absolute increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours, or oliguria (<0.5 mL·kg-¹·h-¹ for ≥6 hours).
  • Severe hepatic dysfunction.
  • Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
  • Known drug or alcohol dependence, difficulty understanding the study protocol, inability or unwillingness to comply with follow-up requirements.
  • Current or planned participation in other clinical trials of drugs or medical devices (post-marketing registry studies permitted).
  • Acute or severe systemic infection.
  • Other conditions deemed unsuitable for participation by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Beijing Anzhen Hospital, affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: To Evaluate the Efficacy and Safety of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Uncontrolled Hypertension Combined With Chronic Kidney Disease

Prospective, Multi-Center, Randomized, Parallel-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radiofrequency（RF) renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with uncontrolled hypertension and chronic kidney disease.

Read the detailed description

The six-channel RF renal denervation system, consisting of the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery radiofrequency denervation.

This Prospective, Multi-Center, Randomized, parallel-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with uncontrolled hypertension and chronic kidney disease, and to provide clinical evidence supporting the expansion of indications. The trial will be conducted by the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Good Clinical Practice for Medical Devices, and other applicable requirements.

Being tested
Six-channel RF Renal Denervation System, Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)
Keywords
Uncontrolled Hypertension, CKD, RDN
Medical subject headings
Hypertension, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Six-channel RF Renal Denervation SystemDevice

    DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)

  • Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)Procedure or surgery

    Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.

Study groups in NCT07130955
Study groupRoleWhat they receive
Renal Denervation (RDN)ExperimentalParticipants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, 12, 24, and 36 months. Assigned Interventions: Device: Six-channel RF Renal Denervation System; Drug: Standardized Antihypertensive Therapy
Receives: Device: Six-channel RF Renal Denervation System
Parallel control with sham operationSham comparatorParticipants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, and 12 months. After completing the 6-month visit, participants may transition to active RDN and then be followed up to 36 months; those declining crossover will continue follow-up at 12，24 and 36 months. Assigned Interventions: Procedure: Sham operation; Drug: Standardized Antihypertensive Therapy
Receives: Procedure: Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM)

    24-hour mean systolic BP measured by validated ambulatory BP monitoring; change is Month 6 minus Baseline.

    Measured: Baseline to Month 6 post-procedure

Secondary outcomes (13)

  1. Change from Baseline in 24-hour Ambulatory Diastolic Blood Pressure at Month 6 (ABPM)

    24-hour mean systolic BP measured by validated ambulatory BP monitoring;

    Measured: Baseline to Month 6 post-procedure

  2. Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)

    24-hour mean systolic BP measured by validated ambulatory BP monitoring;

    Measured: Baseline to Months 1, 3, 12, 24, and 36 post-procedure

  3. Change from Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure (ABPM)

    24-hour mean systolic BP measured by validated ambulatory BP monitoring;

    Measured: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure

  4. Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)

    measured by validated office blood pressure monitoring

    Measured: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure

  5. Percentage of Participants with 24-hour Ambulatory Systolic BP <130 mmHg

    24-hour mean systolic BP measured by validated ambulatory BP monitoring;

    Measured: Months 1, 3, 6, 12, 24, and 36 post-procedure

  6. Percentage of subjects with office systolic BP within the target ranges (<140 mmHg and <130 mmHg)

    measured by validated office blood pressure monitoring

    Measured: Months 1, 3, 6, 12, 24, and 36 post-procedure

  7. Responder Rate: ≥5 mmHg Reduction in 24-hour Ambulatory Systolic BP

    Proportion of participants with a reduction ≥5 mmHg from baseline in 24-hour mean systolic BP by ABPM.

    Measured: Months 1, 3, 6, 12, 24, and 36 post-procedure

  8. Change from Baseline in Antihypertensive Medication Use

    Change in the number of concurrently prescribed antihypertensive agents .

    Measured: Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 1, 3, 6, 12, 24, and 36 post-procedure

  9. Change from Baseline in Cardiac Function (by Echocardiography)

    by Echocardiography

    Measured: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure

  10. Change from Baseline in Heart Rate (by ECG)

    Resting heart rate measured by standard 12-lead ECG; change is Follow-up minus Baseline.

    Measured: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure

  11. Device and Procedure Success

    Successful completion of intended renal denervation ablations in eligible segments of the renal arteries without device malfunction requiring replacement or procedure abortion.

    Measured: Intra-procedure (Day 0)

  12. Periprocedural major adverse event (MAE) rate

    Hospitalization for a clinically significant hypotensive or hypertensive event;

    Vascular complications requiring surgical repair, endovascular therapy, thrombin injection, or blood transfusion;

    Renal artery dissection or perforation requiring intervention;

    Significant embolic events causing end-organ damage or requiring intervention to prevent it;

    Severe renal impairment (>50% decrease in eGFR or >50% increase in serum creatinine from baseline) or ESRD (eGFR <15 mL/min/1.73 m²);

    All-cause death;

    New renal artery stenosis ≥70% (confirmed by angiography).

    Measured: Baseline to 30 days post-procedure

  13. Safety event rates

    Interventional complications: pseudoaneurysm, thrombosis, dissection, AV fistula, rupture or perforation, renal artery stenosis.

    All-cause mortality.

    MACCE: stroke (ischemic or hemorrhagic), ACS (AMI or unstable angina), cardiovascular death.

    Severe renal dysfunction (eGFR decrease >50% or creatinine increase >50% from baseline) or ESRD (eGFR <15 mL/min/1.73 m²).

    New renal artery stenosis ≥70% within 6 months (confirmed by angiography).

    Measured: Baseline to Months 36 post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start8 Aug 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Prospective, Multicenter, Randomized, Parallel-Controlled,The trial will enroll 236 subjects (trial group: control group = 1:1).
Masking
Single blind
Who is masked
Participant
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130955
Sponsor's protocol ID
MLWY-S20250422
Status last verified
Aug 2025
First submitted
28 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

Questions about this trial

What is this clinical trial studying?

A study testing Six-channel RF Renal Denervation System in people with Hypertension and CKD - Chronic Kidney Disease, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.

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 24 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: enrolling by invitation, 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 China. 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM) (time frame: Baseline to Month 6 post-procedure). 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 NCT07130955.

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.

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Clinical Trial NCT07130955 | AzTrials