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

NCT03261375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2023-01-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shanghai Golden Leaf MedTec Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Yujie Zhou, MD · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2022-12-26
Completion
2022-12-26

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261375 on ClinicalTrials.gov