Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study

Not Applicable

• Conditions: Hypertension
• Interventions: Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)

• Registration Number: NCT02672462
• Lead Sponsor: Shanghai Golden Leaf MedTec Co. Ltd

Brief Summary

A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-01
• Last Update Submitted: 2016-02-02
• Study First Posted: 2016-02-03
• Last Update Posted: 2016-02-04
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ages of 18 to 75, male or female;

• Main renal artery, with or without accessary renal arteries, with length

  • 20mm;

• Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and

  • 180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring;

• Agrees to take part in the trial and signs the written, informed consent.

Exclusion Criteria

• Renal artery abnormalities that are inappropriate for the procedure;
• Pregnant or plan to become pregnant;
• History of orthostatic hypotension;
• Type I diabetes;
• Estimated GFR<40mL/min/1.73m2;
• Only one kidney or prior kidney transplantation;
• Bleeding tendency or other coagulation related diseases;
• Acute or severe systemic infection;
• Prior renal artery interventional procedures or prior RDN treatment;
• History of stroke or TIA;
• Malignant tumor or end-stage illnesses;
• Secondary hypertension;
• Acute coronary events within 2 weeks;
• Other conditions that deem unsuitable for the procedure, in the opinions of investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	Radio frequency renal denervation system (Golden Leaf GL-06E15A)	-

Primary Outcome Measures

Name	Time	Method
blood pressure	6 months

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China