Status:
TERMINATED
The Sympara VIBE Study for Hypertension
Lead Sponsor:
Sympara Medical, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02250495
Start Date
October 1 2014
End Date
January 1 2016
Last Update
September 14 2015
Active Locations (3)
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1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
2
Monash Health
Clayton, Victoria, Australia, 3168
3
Barwon Health
Geelong, Victoria, Australia, 3220