Status:
COMPLETED
To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension
Lead Sponsor:
Shanghai Golden Leaf MedTec Co. Ltd
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in treating patients ...
Detailed Description
This is a prospective, multicenter, randomized sham-controlled trial. Patients with uncontrolled hypertension (office BP ≥150/90 and \<180/110mmHg, and average SBP ≥135mmHg by 24-hour ambulatory BP mo...
Eligibility Criteria
Inclusion
- Subject with age of 18 to 65 years old (include 65), male or female;
- Subject with essential hypertension who has an office BP of ≥150/90mmHg and \<180/110 mmHg (both SBP and DBP meet the criteria), and an average SBP of ≥ 135mmHg measured by 24-hour ABPM, after taking ≥ 2 antihypertensive medications for ≥ 4 weeks;
- Subject with the resting heart rate ≥70bpm, if not taking beta-blockers (this criterion does not apply to those taking beta-blockers);
- Subject with confirmed diagnosis of essential hypertension;
- Subject with or without accessary renal arteries;
- Subject who has signed the informed consent form, agrees to participate in this clinical trial, and is willing to comply with the required follow-ups per the trial protocol.
Exclusion
- Subject who is pregnant, nursing or planning to become pregnant during the study;
- Subject with the shape and structure of unilateral or bilateral renal artery that are not suitable for ablation procedure (renal artery stenosis more than 50%, renal aneurysm, renal artery abnormality, renal artery diameter \<4mm or treatable segment length \<20mm);
- Subject who has unilateral kidney or kidney transplant;
- Subject with a history of renal artery interventional therapy or renal denervation;
- Subject with any conditions that may affect the accuracy of blood pressure measurement: such as the diameter of the upper arm is too large relative to the cuff, arrhythmia;
- Subject with secondary hypertension;
- Subject with pseudo-hypertension;
- Subject with orthostatic hypotension;
- Subject with eGFR \<45mL/min/l.73m2;
- Subject with average SBP is \< 135mmHg on 24-hour ABPM;
- Subject with a history of hospitalization for hypertensive emergency within past one year;
- Subject with type I diabetes mellitus;
- Subject with primary pulmonary hypertension;
- Subject with a history of bleeding diathesis and hematological disorders;
- Subject with a history of embolism within past 6 months;
- Subject with a history of acute coronary syndrome within past 6 months;
- Subject with a history of ventricular fibrillation, polymorphic ventricular tachycardia within past 6 months;
- Subject with serum HIV-positive;
- Subject who is allergic to contrast agents;
- Subject with mental illness or any psychological problems that may interfere with the participating in the study;
- Subject with a history of stroke or transient ischemic attack (TIA) within past 3 months;
- Subject with malignant tumors or end-stage disease;
- Subject with severe peripheral vascular disease or abdominal aortic aneurysm;
- Subject with severe heart valve stenosis;
- Subject with cardiac insufficiency (NYHA class III\~IV);
- Subject with hyperthyroidism or hypothyroidism;
- Subject with severe electrolyte or liver function abnormalities;
- Subject who requires mechanical ventilation other than nocturnal respiratory support for sleep apnea;
- Subject with acute or severe systemic infection;
- Subject with a history of pacemaker implantation;
- Subject with a history of major surgery or trauma within 30 days prior to enrollment;
- Subject who has planned surgery or cardiovascular intervention within the next 6 months;
- Subject who is participating in other drug or medical device clinical trials;
- Subject who has known drug or alcohol dependence, difficulty to understand the trial protocol, inability/unwillingness to follow the trial protocol;
- Subject who is unsuitable for participating in this study in the opinion of investigators;
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2022
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03261375
Start Date
January 19 2021
End Date
December 26 2022
Last Update
January 4 2023
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
3
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
4
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China, 050030