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 @ 1:56 PM
Ignite Modification Date:
2025-12-24 @ 1:56 PM
NCT ID:
NCT02926495
Eligibility Criteria:
Inclusion Criteria:
* Individual is ≥30 and \<75 years of age at the time of randomization.
* Individual is receiving a stable medication regimen including maximally tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 4 weeks prior to screening) that is expected to be maintained without changes for at least 6 months post randomization.
* Individual has an office systolic BP ≥140 mmHg and ≤180 mmHg and diastolic BP ≥80 mmHg and ≤110 mmHg measured at an initial screening visit and a confirmatory baseline visit.
* Individual has a 24 hour ambulatory systolic BP of ≥135 mmHg and ≤175 mmHg at baseline.
Exclusion Criteria:
* Individual in whom medications are expected to change in the next 9 months (6 months post randomization).
* Individual does not agree to have all study procedures performed, and is not competent and willing to provide written, informed consent to participate in this clinical study.
* Individual has type 1 diabetes mellitus or type 2 diabetes mellitus with an A1C ≥ 9%.
* Individual has experienced, within one year of the screening visit, a myocardial infarction, hospitalized unstable angina pectoris, hospitalized heart failure, TIA or a cerebrovascular accident.
* Individual has a scheduled or planned surgery, cardiovascular intervention, or dialysis in the next six months.
* Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
* Individual has any serious medical condition with a prognosis of \<2 years.
* Individual has significant anemia (hemoglobin \<100g/L), thrombocytopenia (platelets \<100x10(9) /L) or a severe bleeding disorder eg. hemophilia.
* Individual has known secondary hypertension including primary aldosteronism (other than associated with obstructive sleep apnea).
* Individual has pulmonary hypertension.
* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
* Individual is pregnant, nursing or planning to become pregnant.
* Individual has known or suspected history of medication non-compliance.
* Individual has known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
* Individual has undergone renal denervation or baroreflex activation therapy.
* Individual has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2.
* Individual has another implantable stimulation device including a cardiac pacemaker, ICD, spinal cord stimulator, brain stimulator, vagus nerve stimulator, peripheral nerve stimulator, or cochlear implant.
* Individual is scheduled to have an MRI.
* Individual is currently enrolled in another investigational drug or device trial that has not reached its primary endpoint.
* Individual is working nights or is on a rotating work schedule.
* Individual has an arm circumference too large or small to allow accurate blood pressure measurement with available devices.
* Individual has a history of carpal tunnel syndrome/wrist surgery or other pre-existing compression or non-compression neuropathy in the forearm, wrist or hands that is incompatible with device placement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
74 Years
Study:
NCT02926495
Study Brief:
Protocol Section:
NCT02926495