NCT03261375

To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension

Prospective Multicenter Randomized Parallel Controlled Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Renal Denervation System for the Treatment of Essential Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Shanghai Golden Leaf MedTec Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in treating patients with uncontrolled essential hypertension.

Detailed description

This is a prospective, multicenter, randomized sham-controlled trial. Patients with uncontrolled hypertension (office BP ≥150/90 and \<180/110mmHg, and average SBP ≥135mmHg by 24-hour ambulatory BP monitoring (ABPM), after taking ≥2 antihypertensive drugs with stable dose for ≥ 4 weeks) were screened after informed consent. All eligible patients first entered a lead-in period for ≥4 weeks of standardized medication (Nifedipine + hydrochlorothiazide), and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to RDN group and sham control group (renal artery angiography only). All continued with the 2-drug regimen and were evaluated at 7, 30, 60, 90 and 180 days post procedure. Both patients and site investigators who evaluate the patients were blinded to treatment assignment. The primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post procedure and safety events.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Renal Artery Radiofrequency Ablation System (Generator and Catheter )	A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator
DRUG	Antihypertensive Agents	Calcium channel blocker, Diuretic
DEVICE	Sham Procedure	Catheterization without renal denervation

Timeline

• Start date: 2021-01-19
• Primary completion: 2022-12-26
• Completion: 2022-12-26
• First posted: 2017-08-25
• Last updated: 2023-01-04

Locations

25 sites across 1 country: China