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

February 2, 2016 updated by: Shanghai Golden Leaf MedTec Co. Ltd

The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital
        • Contact:
          • Gengshan Ma, MD
          • Phone Number: (86)13002580569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal denervation
Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Golden Leaf MedTec Co. Ltd

Investigators

  • Principal Investigator: Gengshan Ma, MD, Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL-CT-20150301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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