To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Renal Denervation Read More

Inclusion Criteria:

1. Subject with age of 18 to 65 years old (include 65), male or female;
2. 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;
3. Subject with the resting heart rate ≥70bpm, if not taking beta-blockers (this criterion does not apply to those taking beta-blockers);
4. Subject with confirmed diagnosis of essential hypertension;
5. Subject with or without accessary renal arteries;
6. 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 Criteria:

1. Subject who is pregnant, nursing or planning to become pregnant during the study;
2. 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);
3. Subject who has unilateral kidney or kidney transplant;
4. Subject with a history of renal artery interventional therapy or renal denervation;
5. 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;
6. Subject with secondary hypertension;
7. Subject with pseudo-hypertension;
8. Subject with orthostatic hypotension;
9. Subject with eGFR <45mL/min/l.73m2;
10. Subject with average SBP is < 135mmHg on 24-hour ABPM;
11. Subject with a history of hospitalization for hypertensive emergency within past one year;
12. Subject with type I diabetes mellitus;
13. Subject with primary pulmonary hypertension;
14. Subject with a history of bleeding diathesis and hematological disorders;
15. Subject with a history of embolism within past 6 months;
16. Subject with a history of acute coronary syndrome within past 6 months;
17. Subject with a history of ventricular fibrillation, polymorphic ventricular tachycardia within past 6 months;
18. Subject with serum HIV-positive;
19. Subject who is allergic to contrast agents;
20. Subject with mental illness or any psychological problems that may interfere with the participating in the study;
21. Subject with a history of stroke or transient ischemic attack (TIA) within past 3 months;
22. Subject with malignant tumors or end-stage disease;
23. Subject with severe peripheral vascular disease or abdominal aortic aneurysm;
24. Subject with severe heart valve stenosis;
25. Subject with cardiac insufficiency (NYHA class III~IV);
26. Subject with hyperthyroidism or hypothyroidism;
27. Subject with severe electrolyte or liver function abnormalities;
28. Subject who requires mechanical ventilation other than nocturnal respiratory support for sleep apnea;
29. Subject with acute or severe systemic infection;
30. Subject with a history of pacemaker implantation;
31. Subject with a history of major surgery or trauma within 30 days prior to enrollment;
32. Subject who has planned surgery or cardiovascular intervention within the next 6 months;
33. Subject who is participating in other drug or medical device clinical trials;
34. Subject who has known drug or alcohol dependence, difficulty to understand the trial protocol, inability/unwillingness to follow the trial protocol;
35. Subject who is unsuitable for participating in this study in the opinion of investigators;