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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672462
• Other study ID #: GL-CT-20150301
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2016
• Last updated: February 2, 2016
• Start date: December 2015

Study information

• Verified date: February 2016
• Source: Shanghai Golden Leaf MedTec Co. Ltd
• Contact: Gengshan Ma, MD
• Phone: (86)13002580569
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Golden Leaf MedTec Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		6 months	No