The Sympara VIBE Study for Hypertension

Study Overview
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Brief Summary
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The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension

Official Title
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VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: Sympara Therapeutic System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician Minimum six- (6) month history of diagnosis and treatment of hypertension Exclusion Criteria: Previous renal denervation or carotid barostimulation implant Secondary causes of hypertension or primary pulmonary hypertension Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery Known or suspected baroreflex failure or significant orthostatic hypotension One or more hospital admissions for a hypertensive crisis within the past year History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques Diabetes mellitus (Type 1) Chronic renal disease requiring dialysis Kidney or liver transplant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sympara Therapeutic System<br>All subjects will wear for the Sympara device for 30 days | Device: Sympara Therapeutic System<br>* Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with serious, device-related adverse events as a measure of safety and tolerability |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy | Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline | 30 days |