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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.

Official Title
-----------------
A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Device: Renal denervation
* Diagnostic Test: Renal angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br>Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications | Device: Renal denervation<br>* After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.<br>* Other names: Renal angiography;Diagnostic Test: Renal angiography<br>* A renal angiography according to standard procedure.<br>|
| Sham Comparator: Renal angiography<br>Renal angiography and maintaining anti-hypertensive medications | Diagnostic Test: Renal angiography<br>* A renal angiography according to standard procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring | Primary effective outcome measure | from baseline to 3 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office systolic blood pressure | Secondary effective outcome measure | from baseline to 3 months post-procedure | 
| Classes of anti-hypertensive medicine taken by participants | Secondary effective outcome measure | 6 months post-procedure | 
| Incidence of achieving target office systolic blood pressure (office SBP<140mmHg) | Secondary effective outcome measure | from 3 months post-procedure to 6 months post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Hypertension, Renal Denervation