Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT02250495
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02250495
Study Brief:
Protocol Section:
NCT02250495