A Real-World Study on the Treatment of Hypertension With Netrod-RDN Renal Artery Radiofrequency Ablation System

NCT ID: NCT07273877

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-07
• Study Completion Date: 2030-12-30

Brief 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 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.

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure

Intervention Type: DEVICE

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.

Interventions

Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• (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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Golden Leaf MedTec Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Capital Medical University Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

MLWY-S240801

Identifier Type: -

Identifier Source: org_study_id