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:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT02282033
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 18 years of age
* Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
* Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
* Subject has office systolic blood pressure measurements \> 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg
Exclusion Criteria:
* Subject has known secondary cause of HTN
* Subject has a history of atrial fibrillation
* Subject has ejection fraction \<50%
* Subject has symptoms of heart failure of NYHA Class II or more
* Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
* Subject is on dialysis
* Subject has estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2
* Subject has prior neurological events (stroke or TIA) or carotid artery disease
* Subject has known autonomic dysfunction
* Subject has a history of clinically significant tachyarrhythmia
* Subject has had previous active device-based treatment for hypertension
* Subject has an existing implant, other than a pacemaker that needs replacing
* Subject with average Systolic BP \>190 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02282033
Study Brief:
Protocol Section:
NCT02282033