HypertensionSTARNCT07664787
Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study
A study testing Six-channel RF Renal Denervation System in people with Hypertension and Grade 1, run by Ruijin Hospital.
Trial summary
Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Grade 1
- 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 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 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
- Hypertension duration longer than 3 months
- Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic/diastolic blood pressure still ≥140/90 mmHg and <160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and <140/90 mmHg;
- 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 or eGFR<40mL/min/1.73m2。
- 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.
- 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.
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- Orthostatic hypotension.
- Type 1 diabetes mellitus.
- 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.
- Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
- Acute or severe systemic infection.
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study
Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.
Read the detailed description
The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation.
This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, 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.
- Conditions
- Hypertension, Grade 1
- 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
- hypertension, renal denervation, grade I
- Medical subject headings
- Hypertension, Lymphoma, Follicular
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 group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Participants 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 and 3 months. Receives: Device: Six-channel RF Renal Denervation System |
| Parallel control with sham operation | Sham comparator | Participants 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 and 3months. 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.
Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups.
the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups.
Measured: 3 months
Secondary outcomes (5)
Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)
24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring;
Measured: Baseline to 3 Months
Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg
24-hour mean BP measured by validated ambulatory BP monitoring;
Measured: Months 3 post-procedure
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
measured by validated office blood pressure monitoring
Measured: Baseline to Months 3 post-procedure
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 3 post-procedure
change from baseline in the time in target range of 24 hour ambulatory blood pressure
24-hour mean BP measured by validated ambulatory BP monitoring;
Measured: Months 3 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shandong First Medical University, Shanghai Institute of Hypertension, Shanghai Golden Leaf MedTec Co. Ltd
- Responsible party
- Principal investigator, Xu jianzhong, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664787
- Sponsor's protocol ID
- Ruijin2026-293
- Acronym
- STAR
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study
- ClinicalTrials.gov ID
- NCT07664787
- Acronym / sponsor ID
- STAR / Ruijin2026-293
- Conditions
- Hypertension, Grade 1
- Keywords
- hypertension, renal denervation, grade I
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shandong First Medical University, Shanghai Institute of Hypertension, Shanghai Golden Leaf MedTec Co. Ltd
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.
Detailed description
The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation.
This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Six-channel RF Renal Denervation SystemParticipants 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 and 3 months. |
| Parallel control with sham operation | Sham comparator | Procedure: Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)Participants 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 and 3months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18 to 65 years inclusive
- Hypertension duration longer than 3 months
- Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic/diastolic blood pressure still ≥140/90 mmHg and <160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and <140/90 mmHg;
- 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.
Key exclusion criteria (17 listed)
- 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 or eGFR<40mL/min/1.73m2。
- 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.
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 |
|---|---|---|
| Six-channel RF Renal Denervation SystemDSA-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) | Device | Renal denervation |
| Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)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. | Procedure or surgery | Parallel control with sham operation |
Primary outcome
Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups.
Time frame: 3 months
the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups.
5 secondary outcomes
Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)
Time frame: Baseline to 3 Months
Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg
Time frame: Months 3 post-procedure
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
Time frame: Baseline to Months 3 post-procedure
Change from Baseline in Antihypertensive Medication Use
Time frame: Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure
change from baseline in the time in target range of 24 hour ambulatory blood pressure
Time frame: Months 3 post-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 24 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Six-channel RF Renal Denervation System in people with Hypertension and Grade 1, run by Ruijin Hospital.
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 17 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jian-Zhong Xu, M.D. Ph.D (+86 21 64370045, jianzhongxv@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.