HypertensionNCT07273877
"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN
An observational study of Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.
Trial summary
This study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to 30 Dec 2030
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with refractory hypertension and those with drug intolerance in the real world
Who may be able to join
- (1) Patients who have already used or are planning to use the Netrod-RDN renal artery radiofrequency ablation system for RDN surgery;
- (2) Patients understand the requirements and treatment of this clinical study, agree to follow the requirements of this clinical study for follow-up, and sign the informed consent form before undergoing any special examinations and operations related to the study.
Who cannot join
- Patients with contraindications for RDN surgery and/or those who the researchers consider unsuitable for RDN or who do not wish to participate in this study.
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
Capital Medical University Beijing Anzhen Hospital
Beijing, Beijing Municipality
About this study
Official title: Main Objective: To Evaluate the Long-term Safety and Efficacy of Using the Netrod-RDN Renal Artery Radiofrequency Ablation System in Treating Patients With Refractory Hypertension and Those With Hypertension Who Are Intolerant to Medication in the Real-world Setting
This study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by Shanghai Meiliweiye Medical Technology Co., Ltd. was used to perform percutaneous renal denervation (RDN) on patients with refractory hypertension and drug intolerance in the real world. Refractory hypertension is defined as patients whose blood pressure remains uncontrolled despite taking three or more antihypertensive drugs (including one diuretic) for more than three months; drug intolerance refers to patients who have contraindications to drugs or cannot tolerate drug administration due to adverse drug reactions.
Read the detailed description
All the subjects who were enrolled and received RDN treatment were followed up until 36 months after the surgery. Blood pressure was measured and the antihypertensive effect was evaluated at regular intervals at 7 days after RDN or before discharge (whichever came first), 30 days (±7 days) after the surgery, 3 months (±14 days), 6 months (±30 days), 12 months (±30 days), 24 months (±30 days), and 36 months (±30 days) during the follow-up. Dynamic safety data monitoring was conducted for the subjects throughout the entire study process.
- Conditions
- Hypertension
- Being tested
- Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedureDevice
The disposable mesh renal artery radiofrequency ablation catheter is a spiral-arranged 6-point mesh system. Once The use of a meshed renal artery radiofrequency ablation catheter in combination with a dedicated renal artery radiofrequency ablation device delivers radiofrequency energy to the inner wall of the renal artery, generating appropriate high temperatures to damage or partially damage the renal sympathetic nerves. This device has real-time temperature, power and impedance monitoring functions, providing real-time ablation feedback. It also has the function of real-time recording of ablation data and saving the data.
| Study group | Role | What they receive |
|---|---|---|
| Refractory hypertension and hypertension with drug intolerance Patient | For patients who have been taking more than three types of antihypertensive drugs (including one diuretic) for more than 3 months and whose blood pressure has not been controlled adequately; drug intolerance refers to patients who cannot tolerate the medication due to drug contraindications or adverse drug reactions. Receives: Device: Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)
Measured: Time Frame: Baseline to Month 6 post-procedure.
Secondary outcomes (10)
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
Measured: Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.
Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)
Measured: Baseline to 3, 12, 24, and 36 months post-procedure
Change from Baseline in Home Blood Pressure (including both systolic and diastolic BP)
Measured: Time Frame: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure.
Change from Baseline in Antihypertensive Medication Load (calculated based on the dosage and types of antihypertensive agents).
Measured: Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.
Proportion of Participants Achieving Blood Pressure Targets (Office, Home, and 24-hour Ambulatory; including both systolic and diastolic BP)
Office BP target <140/90 mmHg or <130/80 mmHg; Home BP target <135/85 mmHg; 24-hour ambulatory BP target <130/80 mmHg.
Measured: At the same assessment time points as the above BP measurements (office, home, and 24-hour ambulatory BP).
24-hour Time in Target Range for Ambulatory Blood Pressure (percentage of time meeting daytime <135/85 mmHg and nighttime <120/70 mmHg thresholds)
Measured: Months 6, 12, and 36 post-procedure.
Change from Baseline in SF-12 Health-Related Quality of Life Score (for heart failure subgroup only)
The SF-12 Health-Related Quality of Life Score includes Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, using a norm-based system and not bonded by an absolute maximum or minimum, a higher SF-12 score on either the PCS or the MCS means a better health-related quality of life. Comparing the SF-12 scores before and after treatment can evaluate the improvement of the treatment on patient's daily quality of life.
Measured: Baseline to Months 12 and 36 post-procedure.
Change from Baseline in Six-Minute Walk Distance (meters; heart failure subgroup only)
Measured: Baseline to Months 6, 12, 24, and 36 post-procedure.
Periprocedural major adverse event (MAE) rate
All-cause death;
ESRD (eGFR <15 mL/min/1.73 m² or initiation of dialysis) or CKD progression (>50% decrease in eGFR or >50% increase in serum creatinine from baseline);
Major thromboembolic events causing end-organ damage or requiring intervention to prevent it;
Major vascular complications requiring surgical or endovascular intervention, including renal artery perforation, dissection, aneurysm, etc., and access-site vascular complications requiring intervention (e.g., hematoma, bleeding, arteriovenous fistula, etc.);
Hospitalization for hypertensive crisis or significant hypotension not attributable to poor adherence to antihypertensive therapy;
New renal artery stenosis >70% (confirmed by angiography).
Measured: Baseline to 30 days post-procedure
Safety event rates
All-cause mortality;
ESRD (CKD stage 5; eGFR <15 mL/min/1.73 m²) or CKD progression (>50% decrease in eGFR from baseline or >50% increase in serum creatinine from baseline);
Major thromboembolic events causing end-organ damage or requiring intervention to prevent it;
Hospitalization for hypertensive crisis or clinically significant hypotension (not attributable to poor adherence to antihypertensives);
New renal artery stenosis >70% (confirmed by angiography);
New-onset acute coronary syndrome (ACS);
New stroke, transient ischemic attack (TIA), or other major cerebrovascular events;
Rehospitalization for worsening heart failure (HF subgroup only).
Measured: Baseline to Month 36 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start7 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2030 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273877
- Sponsor's protocol ID
- MLWY-S240801
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Objective: To Evaluate the Long-term Safety and Efficacy of Using the Netrod-RDN Renal Artery Radiofrequency Ablation System in Treating Patients With Refractory Hypertension and Those With Hypertension Who Are Intolerant to Medication in the Real-world Setting
- ClinicalTrials.gov ID
- NCT07273877
- Acronym / sponsor ID
- MLWY-S240801
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 10 Dec 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 study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by Shanghai Meiliweiye Medical Technology Co., Ltd. was used to perform percutaneous renal denervation (RDN) on patients with refractory hypertension and drug intolerance in the real world. Refractory hypertension is defined as patients whose blood pressure remains uncontrolled despite taking three or more antihypertensive drugs (including one diuretic) for more than three months; drug intolerance refers to patients who have contraindications to drugs or cannot tolerate drug administration due to adverse drug reactions.
Detailed description
All the subjects who were enrolled and received RDN treatment were followed up until 36 months after the surgery. Blood pressure was measured and the antihypertensive effect was evaluated at regular intervals at 7 days after RDN or before discharge (whichever came first), 30 days (±7 days) after the surgery, 3 months (±14 days), 6 months (±30 days), 12 months (±30 days), 24 months (±30 days), and 36 months (±30 days) during the follow-up. Dynamic safety data monitoring was conducted for the subjects throughout the entire study process.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractory hypertension and hypertension with drug intolerance Patient | – | Device: Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedureFor patients who have been taking more than three types of antihypertensive drugs (including one diuretic) for more than 3 months and whose blood pressure has not been controlled adequately; drug intolerance refers to patients who cannot tolerate the medication due to drug contraindications or adverse drug reactions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with refractory hypertension and those with drug intolerance in the real world
Key inclusion criteria (2 listed)
- (1) Patients who have already used or are planning to use the Netrod-RDN renal artery radiofrequency ablation system for RDN surgery;
- (2) Patients understand the requirements and treatment of this clinical study, agree to follow the requirements of this clinical study for follow-up, and sign the informed consent form before undergoing any special examinations and operations related to the study.
Key exclusion criteria (1 listed)
- Patients with contraindications for RDN surgery and/or those who the researchers consider unsuitable for RDN or who do not wish to participate in this study.
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 |
|---|---|---|
| Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedureThe disposable mesh renal artery radiofrequency ablation catheter is a spiral-arranged 6-point mesh system. Once The use of a meshed renal artery radiofrequency ablation catheter in combination with a dedicated renal artery radiofrequency ablation device delivers radiofrequency energy to the inner wall of the renal artery, generating appropriate high temperatures to damage or partially damage the renal sympathetic nerves. This device has real-time temperature, power and impedance monitoring functions, providing real-time ablation feedback. It also has the function of real-time recording of ablation data and saving the data. | Device | Refractory hypertension and hypertension with drug intolerance Patient |
Primary outcome
Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)
Time frame: Time Frame: Baseline to Month 6 post-procedure.
10 secondary outcomes
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
Time frame: Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.
Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)
Time frame: Baseline to 3, 12, 24, and 36 months post-procedure
Change from Baseline in Home Blood Pressure (including both systolic and diastolic BP)
Time frame: Time Frame: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure.
Change from Baseline in Antihypertensive Medication Load (calculated based on the dosage and types of antihypertensive agents).
Time frame: Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.
Proportion of Participants Achieving Blood Pressure Targets (Office, Home, and 24-hour Ambulatory; including both systolic and diastolic BP)
Time frame: At the same assessment time points as the above BP measurements (office, home, and 24-hour ambulatory BP).
24-hour Time in Target Range for Ambulatory Blood Pressure (percentage of time meeting daytime <135/85 mmHg and nighttime <120/70 mmHg thresholds)
Time frame: Months 6, 12, and 36 post-procedure.
Change from Baseline in SF-12 Health-Related Quality of Life Score (for heart failure subgroup only)
Time frame: Baseline to Months 12 and 36 post-procedure.
Change from Baseline in Six-Minute Walk Distance (meters; heart failure subgroup only)
Time frame: Baseline to Months 6, 12, 24, and 36 post-procedure.
Periprocedural major adverse event (MAE) rate
Time frame: Baseline to 30 days post-procedure
Safety event rates
Time frame: Baseline to Month 36 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 20 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, 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 2 inclusion and 1 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 20 Apr 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. 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 Blood Pressure (including both systolic and diastolic BP) (time frame: 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?
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 20 Apr 2026.