Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension

Inclusion Criteria:

• Individual is ≥18 years and ≤65 years old.
• Primary hypertension.
• Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and <170mmHg at the fourth week after screening.

Exclusion Criteria:

• Secondary hypertension.
• History of prior renal artery intervention including balloon angioplasty or stenting.
• Renal artery stenosis (≥50%) in either renal artery.
• Main renal arteries with <4mm, or >8mm in diameter.
• Main renal arteries with <20mm in length.
• Estimated glomerular filtration rate (eGFR) of <40 ml/(min•1.73m2).
• History of Stroke or TIA within 6 months prior to screening period.
• History of Acute coronary syndrome within 6 months prior to screening period.
• Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.
• Heart failure (NYHA classification Ⅲ-Ⅳ).
• Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases.
• History of cancer.
• Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring.
• Acute or severe systemic inflammatory response syndrome.
• Any other serious medical condition unqualified to participate in this study evaluated by investigator.