Refractory Hypertension or Drug-intolerant HypertensionNCT07108829
Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension
A study testing Renal Artery Radiofrequency Ablation Clamp in people with Refractory Hypertension or Drug-intolerant Hypertension, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
This is a first-in-human study to test the safety and effectiveness of a new device-based treatment for high blood pressure that is difficult to control with medicine. This condition is known as refractory hypertension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Hypertension or Drug-intolerant Hypertension
- What is being tested?
- Renal Artery Radiofrequency Ablation Clamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Aug 2026
- 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
- Age ≥18 years and ≤65 years, any sex.
- Diagnosed with primary hypertension.
- History of hypertension for at least 6 months.
- Blood pressure meets the following two conditions:
- Office systolic blood pressure ≥140mmHg and ≤180mmHg, and office diastolic blood pressure ≥90mmHg. If not taking a beta-blocker, resting heart rate must be ≥70bpm.
- 24-hour ambulatory blood pressure measurement shows an average systolic pressure ≥130mmHg or a daytime average systolic pressure ≥135mmHg.
- Has a history of antihypertensive medication use within the last 6 months with uncontrolled blood pressure. Before enrollment, must undergo at least 28 days of a standardized medication regimen (including a diuretic and at least three drugs in total) with ≥80% compliance, while office SBP remains ≥140mmHg and ≤180mmHg, and office DBP remains ≥90mmHg.
- Patient is willing and able to comply with follow-up requirements and has signed the informed consent form.
Who cannot join
- Secondary hypertension.
- Target renal artery anatomy is unsuitable, including:
- Renal artery diameter >9mm or <4mm.
- Multiple renal arteries.
- Severe calcification, stenosis >50%, malformation, fibromuscular dysplasia, or aneurysm in either renal artery.
- History of renal artery intervention (e.g., balloon angioplasty or stenting).
Show all 14Show fewer
- Unsuitable for laparoscopic surgery via the retroperitoneal approach, including prior retroperitoneal surgery, retroperitoneal fibrosis, or severe obesity (BMI > 40 kg/m²).
- History of kidney transplant or severe renal impairment (eGFR < 45 mL/min/1.73m²).
- Hospitalization for a hypertensive crisis within the past year.
- Severe liver dysfunction (ALT or AST > 3 times the upper limit of normal).
- Type 1 diabetes.
- History of a cardiovascular event (e.g., myocardial infarction, unstable angina) or cerebrovascular event (e.g., stroke, TIA) within the last 6 months.
- Pregnancy or planning to become pregnant during the trial.
- Participation in any other investigational drug or device trial within 3 months prior to screening.
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
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan
Chuanyu Gao, MD，Phd, 13937165590, gaocy6208@163.com
About this study
Official title: First-in-Man Clinical Study to Evaluate the Safety and Efficacy of Renal Artery Radiofrequency Ablation Clamp, Radiofrequency Ablation Generator for the Adjunctive Treatment of Refractory Hypertension and Drug-Intolerant Hypertension
This is a first-in-human study to test the safety and effectiveness of a new device-based treatment for high blood pressure that is difficult to control with medicine. This condition is known as refractory hypertension.
The study will enroll 10 adults aged 18 to 65 whose high blood pressure is not controlled even though they are taking three or more blood pressure medications.
Read more
The treatment involves a new medical device called a Renal Artery Radiofrequency Ablation Clamp. This device is used during a keyhole (laparoscopic) surgery. It works by applying controlled heat (radiofrequency energy) to the outside of the arteries that supply blood to the kidneys. This procedure, known as renal denervation, aims to calm the nerves around these arteries that contribute to high blood pressure.
Participants who join the study will first be monitored on a standard set of blood pressure medicines to confirm they are eligible. If they qualify, they will undergo the keyhole surgery. After the procedure, participants will be followed for 180 days (about 6 months) and will have several follow-up visits to check their blood pressure and overall health.
Read the detailed description
Rationale: Hypertension is a leading risk factor for cardiovascular disease. A significant portion of patients have refractory hypertension, where blood pressure remains elevated despite the use of multiple antihypertensive medications. The renal sympathetic nervous system plays a crucial role in blood pressure regulation, and its overactivity is a key factor in hypertension. Renal Denervation (RDN) is a device-based therapy designed to lower blood pressure by ablating these nerves. While most existing RDN systems use an endovascular (inside the artery) approach, this method carries potential risks such as endothelial damage, thrombosis, or renal artery stenosis.
Study Objective and Design: This is a prospective, single-center, single-arm, first-in-man (FIM) clinical study designed to provide a preliminary evaluation of the safety and efficacy of a novel laparoscopic adventitial RDN system for treating refractory or drug-intolerant hypertension. A total of 10 subjects will be enrolled. The study aims to gather initial feasibility and safety data to support the design of future, larger clinical trials.
Intervention: The investigational procedure is a laparoscopic renal artery adventitial RDN. This technique involves placing a Renal Artery Radiofrequency Ablation Clamp around the external surface (adventitia) of the main renal arteries. A compatible radiofrequency generator delivers energy to the clamp's electrodes, creating targeted lesions to ablate the sympathetic nerves while preserving the integrity of the arterial wall.
Methodology: Potential subjects will be screened for eligibility. Qualified candidates will enter a 28-day run-in period where they will be treated with a standardized, fixed-dose combination of at least three antihypertensive drugs, including a diuretic. This period is to confirm refractory status and assess medication adherence, which is confirmed via urine analysis. Subjects who still meet the blood pressure criteria after the run-in period will undergo the laparoscopic RDN procedure. Post-procedure, subjects will be followed at discharge (or Day 7), Day 30, Day 90, and Day 180. Antihypertensive medications may be adjusted after 90 days according to a predefined protocol based on blood pressure response. Efficacy will be assessed by changes in office and 24-hour ambulatory blood pressure, as well as changes in medication burden. Safety will be monitored by tracking the incidence of Major Adverse Events (MAE), procedure-related complications, and changes in renal function throughout the 180-day follow-up period.
- Being tested
- Renal Artery Radiofrequency Ablation Clamp
- Keywords
- Hypertension, Resistant Hypertension, Renal Denervation, Laparoscopic, Radiofrequency Ablation, Sympathetic Nerves
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Artery Radiofrequency Ablation ClampDevice
This device is a clamp used during a laparoscopic surgical procedure. It is placed on the external surface (adventitia) of the renal artery and is connected to a radiofrequency generator. It delivers targeted radiofrequency energy to ablate the renal sympathetic nerves.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Adventitial RDN | Experimental | Participants will undergo a 28-day run-in period on a standardized antihypertensive medication regimen. Following this period, all participants will receive the investigational treatment, which is a laparoscopic renal artery adventitial denervation procedure. Participants will be followed for 180 days post-procedure Receives: Device: Renal Artery Radiofrequency Ablation Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Achieving Target Office Systolic Blood Pressure at 180 Days
The percentage of subjects whose office systolic blood pressure (SBP) is less than 140mmHg at the 180-day post-procedure follow-up. Office blood pressure will be measured in a resting state according to a standardized procedure.
Measured: 180 days post-procedure
Change From Baseline in Antihypertensive Medication Composite Score at 180 Days
The change from baseline in a composite score reflecting the type and dose of antihypertensive medication required to achieve a target office SBP of <140mmHg. The score is calculated as (number of drug classes) multiplied by (the sum of the doses), where a standard daily dose is defined as 1, a half dose is 0.5, and a double dose is 2. The change is calculated as the baseline score minus the 180-day score.
Measured: 180 days post-procedure
Secondary outcomes (4)
Procedural Success Rate
The percentage of procedures where the renal artery radiofrequency ablation clamp is successfully positioned and the denervation procedure is completed without related complications, which include renal artery perforation and renal artery embolism.
Measured: Intra-procedural
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure at 180 Days
The reduction in mean 24-hour ambulatory systolic blood pressure (SBP) at 180 days post-procedure compared to the baseline measurement.
Measured: Baseline and 180 days post-procedure
Incidence of Major Adverse Events (MAE)
The percentage of subjects experiencing one or more Major Adverse Events. MAEs include all-cause mortality, new myocardial infarction, major bleeding, end-stage renal disease, major embolic events causing end-organ damage, renal artery re-intervention, renal artery perforation or dissection, vascular complications requiring intervention, hospitalization for hypertensive crisis, new stroke, or new-onset renal artery stenosis (≥70%).
Measured: Up to 180 days post-procedure
Incidence of Laparoscopic Surgery-Related Adverse Events
The percentage of subjects experiencing adverse events related to the laparoscopic procedure. These include pneumoperitoneum-related complications (e.g., gas embolism, pneumothorax), injury to major abdominal or retroperitoneal vessels, visceral injury (bowel, bladder, liver, spleen), or ureteral injury.
Measured: Up to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractory Hypertension or Drug-intolerant 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Ept Medical Co., Ltd., Shanghai Hongtong Industrial Co., Ltd.
- Responsible party
- Principal investigator, Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108829
- Sponsor's protocol ID
- HenanlCE202503
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol's confidentiality section states that all study content and data are confidential and the exclusive property of the sponsor. It specifies that this information cannot be disclosed to any third party without the sponsor's consent , and this obligation of confidentiality remains in effect even after the trial is completed. This indicates there is no plan to share individual participant data.
Publications
Gao C, Zhao L, Zhu L, Li M, Ding D, Liu Z, Fan Z, Zhang Y, Zhao W, Wang J. Laparoscopic-based perivascular unilateral renal sympathetic nerve denervation for treating resistant hypertension: a case report. Hypertens Res. 2019 Aug;42(8):1162-1165. doi: 10.1038/s41440-019-0237-3. Epub 2019 Feb 27.
PubMed 30814662Baik J, Song WH, Yim D, Lee S, Yang S, Lee HY, Choi EK, Jeong CW, Park SM. Laparoscopic Renal Denervation System for Treating Resistant Hypertension: Overcoming Limitations of Catheter-Based Approaches. IEEE Trans Biomed Eng. 2020 Dec;67(12):3425-3437. doi: 10.1109/TBME.2020.2987531. Epub 2020 Nov 19.
PubMed 32310758Liu Y, Zhu B, Zhu L, Zhao L, Ding D, Liu Z, Fan Z, Zhao Q, Zhang Y, Wang J, Gao C. Clinical outcomes of laparoscopic-based renal denervation plus adrenalectomy vs adrenalectomy alone for treating resistant hypertension caused by unilateral aldosterone-producing adenoma. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1606-1615. doi: 10.1111/jch.13963. Epub 2020 Aug 18.
PubMed 32812324Zhao L, Su E, Yang X, Zhu B, Fan Z, Wang X, Qi D, Zhu L, Bai M, Zhang Y, Zhao Q, Li M, Gao C. Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model. Eur J Med Res. 2020 Jun 18;25(1):22. doi: 10.1186/s40001-020-00422-5.
PubMed 32552871Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.
PubMed 19332353
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Man Clinical Study to Evaluate the Safety and Efficacy of Renal Artery Radiofrequency Ablation Clamp, Radiofrequency Ablation Generator for the Adjunctive Treatment of Refractory Hypertension and Drug-Intolerant Hypertension
- ClinicalTrials.gov ID
- NCT07108829
- Acronym / sponsor ID
- HenanlCE202503
- Keywords
- Hypertension, Resistant Hypertension, Renal Denervation, Laparoscopic, Radiofrequency Ablation, Sympathetic Nerves
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Collaborators
- Hunan Ept Medical Co., Ltd., Shanghai Hongtong Industrial Co., Ltd.
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Aug 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 is a first-in-human study to test the safety and effectiveness of a new device-based treatment for high blood pressure that is difficult to control with medicine. This condition is known as refractory hypertension.
The study will enroll 10 adults aged 18 to 65 whose high blood pressure is not controlled even though they are taking three or more blood pressure medications.
The treatment involves a new medical device called a Renal Artery Radiofrequency Ablation Clamp. This device is used during a keyhole (laparoscopic) surgery. It works by applying controlled heat (radiofrequency energy) to the outside of the arteries that supply blood to the kidneys. This procedure, known as renal denervation, aims to calm the nerves around these arteries that contribute to high blood pressure.
Participants who join the study will first be monitored on a standard set of blood pressure medicines to confirm they are eligible. If they qualify, they will undergo the keyhole surgery. After the procedure, participants will be followed for 180 days (about 6 months) and will have several follow-up visits to check their blood pressure and overall health.
Detailed description
Rationale: Hypertension is a leading risk factor for cardiovascular disease. A significant portion of patients have refractory hypertension, where blood pressure remains elevated despite the use of multiple antihypertensive medications. The renal sympathetic nervous system plays a crucial role in blood pressure regulation, and its overactivity is a key factor in hypertension. Renal Denervation (RDN) is a device-based therapy designed to lower blood pressure by ablating these nerves. While most existing RDN systems use an endovascular (inside the artery) approach, this method carries potential risks such as endothelial damage, thrombosis, or renal artery stenosis.
Study Objective and Design: This is a prospective, single-center, single-arm, first-in-man (FIM) clinical study designed to provide a preliminary evaluation of the safety and efficacy of a novel laparoscopic adventitial RDN system for treating refractory or drug-intolerant hypertension. A total of 10 subjects will be enrolled. The study aims to gather initial feasibility and safety data to support the design of future, larger clinical trials.
Intervention: The investigational procedure is a laparoscopic renal artery adventitial RDN. This technique involves placing a Renal Artery Radiofrequency Ablation Clamp around the external surface (adventitia) of the main renal arteries. A compatible radiofrequency generator delivers energy to the clamp's electrodes, creating targeted lesions to ablate the sympathetic nerves while preserving the integrity of the arterial wall.
Methodology: Potential subjects will be screened for eligibility. Qualified candidates will enter a 28-day run-in period where they will be treated with a standardized, fixed-dose combination of at least three antihypertensive drugs, including a diuretic. This period is to confirm refractory status and assess medication adherence, which is confirmed via urine analysis. Subjects who still meet the blood pressure criteria after the run-in period will undergo the laparoscopic RDN procedure. Post-procedure, subjects will be followed at discharge (or Day 7), Day 30, Day 90, and Day 180. Antihypertensive medications may be adjusted after 90 days according to a predefined protocol based on blood pressure response. Efficacy will be assessed by changes in office and 24-hour ambulatory blood pressure, as well as changes in medication burden. Safety will be monitored by tracking the incidence of Major Adverse Events (MAE), procedure-related complications, and changes in renal function throughout the 180-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Adventitial RDN | Experimental | Device: Renal Artery Radiofrequency Ablation ClampParticipants will undergo a 28-day run-in period on a standardized antihypertensive medication regimen. Following this period, all participants will receive the investigational treatment, which is a laparoscopic renal artery adventitial denervation procedure. Participants will be followed for 180 days post-procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤65 years, any sex.
- Diagnosed with primary hypertension.
- History of hypertension for at least 6 months.
- Office systolic blood pressure ≥140mmHg and ≤180mmHg, and office diastolic blood pressure ≥90mmHg. If not taking a beta-blocker, resting heart rate must be ≥70bpm.
- 24-hour ambulatory blood pressure measurement shows an average systolic pressure ≥130mmHg or a daytime average systolic pressure ≥135mmHg.
Key exclusion criteria (14 listed)
- Secondary hypertension.
- Renal artery diameter >9mm or <4mm.
- Multiple renal arteries.
- Severe calcification, stenosis >50%, malformation, fibromuscular dysplasia, or aneurysm in either renal artery.
- History of renal artery intervention (e.g., balloon angioplasty or stenting).
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 |
|---|---|---|
| Renal Artery Radiofrequency Ablation ClampThis device is a clamp used during a laparoscopic surgical procedure. It is placed on the external surface (adventitia) of the renal artery and is connected to a radiofrequency generator. It delivers targeted radiofrequency energy to ablate the renal sympathetic nerves. | Device | Laparoscopic Adventitial RDN |
Primary outcome
Rate of Achieving Target Office Systolic Blood Pressure at 180 Days
Time frame: 180 days post-procedure
The percentage of subjects whose office systolic blood pressure (SBP) is less than 140mmHg at the 180-day post-procedure follow-up. Office blood pressure will be measured in a resting state according to a standardized procedure.
Change From Baseline in Antihypertensive Medication Composite Score at 180 Days
Time frame: 180 days post-procedure
The change from baseline in a composite score reflecting the type and dose of antihypertensive medication required to achieve a target office SBP of <140mmHg. The score is calculated as (number of drug classes) multiplied by (the sum of the doses), where a standard daily dose is defined as 1, a half dose is 0.5, and a double dose is 2. The change is calculated as the baseline score minus the 180-day score.
4 secondary outcomes
Procedural Success Rate
Time frame: Intra-procedural
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure at 180 Days
Time frame: Baseline and 180 days post-procedure
Incidence of Major Adverse Events (MAE)
Time frame: Up to 180 days post-procedure
Incidence of Laparoscopic Surgery-Related Adverse Events
Time frame: Up to 30 days 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 7 Aug 2025.
- Background: PubMed 30814662Gao C, Zhao L, Zhu L, Li M, Ding D, Liu Z, Fan Z, Zhang Y, Zhao W, Wang J. Laparoscopic-based perivascular unilateral renal sympathetic nerve denervation for treating resistant hypertension: a case report. Hypertens Res. 2019 Aug;42(8):1162-1165. doi: 10.1038/s41440-019-0237-3. Epub 2019 Feb 27.
- Background: PubMed 32310758Baik J, Song WH, Yim D, Lee S, Yang S, Lee HY, Choi EK, Jeong CW, Park SM. Laparoscopic Renal Denervation System for Treating Resistant Hypertension: Overcoming Limitations of Catheter-Based Approaches. IEEE Trans Biomed Eng. 2020 Dec;67(12):3425-3437. doi: 10.1109/TBME.2020.2987531. Epub 2020 Nov 19.
- Background: PubMed 32812324Liu Y, Zhu B, Zhu L, Zhao L, Ding D, Liu Z, Fan Z, Zhao Q, Zhang Y, Wang J, Gao C. Clinical outcomes of laparoscopic-based renal denervation plus adrenalectomy vs adrenalectomy alone for treating resistant hypertension caused by unilateral aldosterone-producing adenoma. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1606-1615. doi: 10.1111/jch.13963. Epub 2020 Aug 18.
- Background: PubMed 32552871Zhao L, Su E, Yang X, Zhu B, Fan Z, Wang X, Qi D, Zhu L, Bai M, Zhang Y, Zhao Q, Li M, Gao C. Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model. Eur J Med Res. 2020 Jun 18;25(1):22. doi: 10.1186/s40001-020-00422-5.
- Background: PubMed 19332353Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.
- Individual participant dataSharing planned: No. The protocol's confidentiality section states that all study content and data are confidential and the exclusive property of the sponsor. It specifies that this information cannot be disclosed to any third party without the sponsor's consent , and this obligation of confidentiality remains in effect even after the trial is completed. This indicates there is no plan to share individual participant data.
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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 Renal Artery Radiofrequency Ablation Clamp in people with Refractory Hypertension or Drug-intolerant Hypertension, run by Henan Institute of Cardiovascular Epidemiology 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 8 inclusion and 14 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 7 Aug 2025. 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?
Contact Chuanyu Gao, MD, Phd (13937165590, gaocy6208@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Achieving Target Office Systolic Blood Pressure at 180 Days (time frame: 180 days post-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 NCT07108829, which also lists 5 linked publications.
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 7 Aug 2025.