The Sympara VIBE Study for Hypertension

Sympara Medical

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Hypertension

Treatments

Device: Sympara Therapeutic System

Study type

Interventional

Funder types

Industry

Identifiers

STS1402

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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