Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 7:34 AM
Study NCT ID:
NCT01471834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2011-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension
Sponsor:
CVRx, Inc.
Organization:
Study Overview
Official Title:
Neo Non-Randomized Hypertension Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: