The Sympara VIBE Study for Hypertension

Phase 1

Terminated

• Conditions: Hypertension
• Interventions: Device: Sympara Therapeutic System

• Registration Number: NCT02250495
• Lead Sponsor: Sympara Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-20
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-26
• Study Start: 2014-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-11
• Last Update Posted: 2015-09-14
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sympara Therapeutic System	Sympara Therapeutic System	All subjects will wear for the Sympara device for 30 days

Primary Outcome Measures

Name	Time	Method
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability	30 days

Secondary Outcome Measures

Name	Time	Method
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy	30 days	Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline

Trial Locations

Locations (3)

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Barwon Health; 🇦🇺 Geelong, Victoria, Australia

Monash Health; 🇦🇺 Clayton, Victoria, Australia