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

Shanghai Golden Leaf MedTec

Status

Unknown

Conditions

Hypertension

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

GL-CT-20150301

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.