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A Real-World Study on the Treatment of Hypertension With Netrod-RDN Renal Artery Radiofrequency Ablation System
Sponsor: Shanghai Golden Leaf MedTec Co. Ltd
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2025-08-07
Completion Date
2030-12-30
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
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.
Locations (1)
Capital Medical University Beijing Anzhen Hospital
Beijing, Beijing Municipality, China