eo* Randomized Hypertension Study

Withdrawn

• Conditions: refractory high blood pressure; therapy-resistant hypertension; 10057166

• Registration Number: NL-OMON37975
• Lead Sponsor: CVRx Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Age at least 21 years and no more than 80 years. Office cuff systolic blood pressure (SBP) >= 140 mmHg (for the Netherlands >= 160 mmHg) Normal anatomy of carotic artery bifurcations An optimal stable anti-hypertensive therapy not pregnant and contemplating pregnancy during study period compliant on therapy

Exclusion Criteria

known of suspected baroreflex failure or autonomic neuropathy Body Mass Index above 45 Myocardial Infarction, unstable angina, syncope or CVA within the past 3 months Carotic atherosclerosis producing a 50% or greater reduction in diameter Prior surgery, radiation, or endovascular stent placement in the carotid sinus region Hypertension secondary to an identifiable and treatable cause other than sleep apnoea.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1 Primary Efficacy Objective<br /><br>To assess the difference between randomized groups in the reduction in office<br /><br>cuff systolic blood pressure through six months, relative to the average of the<br /><br>screening blood pressure measurements.<br /><br>2 Primary Safety Objective<br /><br>To describe the safety of Baroreflex Activation Therapy utilizing the Neo<br /><br>system by evaluating all adverse events and estimating the rate of all system<br /><br>and procedure related complications through the 6-month visit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NVT</p><br>