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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radio frequency renal denervation system (Golden Leaf GL-06E15A)
Sponsored by
Shanghai Golden Leaf MedTec Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongda HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal denervation

Arm Description

Outcomes

Primary Outcome Measures

blood pressure

Secondary Outcome Measures

Full Information

First Posted
February 1, 2016
Last Updated
February 2, 2016
Sponsor
Shanghai Golden Leaf MedTec Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02672462
Brief Title
Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study
Official Title
The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Golden Leaf MedTec Co. Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radio frequency renal denervation system (Golden Leaf GL-06E15A)
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gengshan Ma, MD
Phone
(86)13002580569
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gengshan Ma, MD
Organizational Affiliation
Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gengshan Ma, MD
Phone
(86)13002580569

12. IPD Sharing Statement

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

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