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

Not Applicable

• Conditions: Primary Hypertension

• Registration Number: NCT03511313
• Lead Sponsor: Synaptic Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Status Verified: 2018-04
• Study Start: 2018-04-11
• Study First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Study First Posted: 2018-04-27
• Last Update Posted: 2018-04-27
• Primary Completion: 2020-06
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China