The Sympara VIBE Study for Hypertension

NCT ID: NCT02250495

Last Updated: 2015-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sympara Therapeutic System

All subjects will wear for the Sympara device for 30 days

Group Type EXPERIMENTAL

Sympara Therapeutic System

Intervention Type DEVICE

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

Interventions

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Sympara Therapeutic System

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sympara Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Meredith, AM, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash Health

Locations

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Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Monash Health

Clayton, Victoria, Australia

Site Status

Barwon Health

Geelong, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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STS1402

Identifier Type: -

Identifier Source: org_study_id

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