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

Synaptic Medical Corporation1 site in 1 country264 target enrollmentApril 11, 2018

ConditionsPrimary Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Hypertension
Sponsor: Synaptic Medical Corporation
Enrollment: 264
Locations: 1
Primary Endpoint: Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2018

End Date

September 2020

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Synaptic Medical Corporation

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring

Time Frame: from baseline to 3 months post-procedure

Primary effective outcome measure

Secondary Outcomes

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