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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Sympara VIBE Study for Hypertension
Scientific title
VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Devices - Sympara Therapeutic System

Experimental: Sympara Therapeutic System - All subjects will wear for the Sympara device for 30 days

Treatment: Devices: Sympara Therapeutic System
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
30 days

Key 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
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Sympara Medical, Inc.

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Ian Meredith, AM, PhD
Address 0 0
Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see