Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study
NCT ID: NCT02672462
Last Updated: 2016-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Renal denervation
Radio frequency renal denervation system (Golden Leaf GL-06E15A)
Interventions
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Radio frequency renal denervation system (Golden Leaf GL-06E15A)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Golden Leaf MedTec Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Gengshan Ma, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital
Locations
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Zhongda Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Gengshan Ma, MD
Role: CONTACT
Facility Contacts
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Gengshan Ma, MD
Role: primary
Other Identifiers
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GL-CT-20150301
Identifier Type: -
Identifier Source: org_study_id
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