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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02672462
Recruitment Status : Unknown
Verified February 2016 by Shanghai Golden Leaf MedTec Co. Ltd.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study
Study Start Date : December 2015
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. blood pressure [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02672462

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Contact: Gengshan Ma, MD (86)13002580569

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China, Jiangsu
Zhongda Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Gengshan Ma, MD    (86)13002580569      
Sponsors and Collaborators
Shanghai Golden Leaf MedTec Co. Ltd
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Principal Investigator: Gengshan Ma, MD Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital
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Responsible Party: Shanghai Golden Leaf MedTec Co. Ltd Identifier: NCT02672462    
Other Study ID Numbers: GL-CT-20150301
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases