The Sympara VIBE Study for Hypertension

Hypertension Clinical Trial

— VIBE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02250495
• Other study ID #: STS1402
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 20, 2014
• Last updated: September 11, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: September 2015
• Source: Sympara Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Sympara Medical, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with serious, device-related adverse events as a measure of safety and tolerability		30 days	Yes
Secondary	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	No