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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT03314012
Eligibility Criteria:
Inclusion Criteria:
* Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
* Mean daytime systolic ABPM ≥135 mmHg during screen-in period
* Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure
* No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
* Negative pregnancy test for women of child-bearing age
* Willingness and able to comply with follow-up requirements
* Signed informed consent
Exclusion Criteria:
* Secondary causes of hypertension
* Calculated eGFR \<30mL/min/1.73m2
* History of repeated episodes of hypoglycemic unawareness
* Morbid obesity, defined as Body Mass Index \>40 kg/m2
* Severe obstructive sleep apnea (AHI \> 35/hr.)
* Pacemaker and/or implantable defibrillators
* History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
* History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
* History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03314012
Study Brief:
Protocol Section:
NCT03314012