Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT01471834
Brief Summary:
To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.
Detailed Description:
The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.
Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
* Physical Assessment
* Office Cuff Blood Pressure
* Subject Medications
* Serious adverse events
Study:
NCT01471834
Study Brief:
Protocol Section:
NCT01471834