Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT01679132
Status:
SUSPENDED
Last Update Posted:
2025-07-15
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAROSTIM NEO Hypertension Pivotal Trial
Sponsor:
CVRx, Inc.
Organization:
Study Overview
Official Title:
BAROSTIM NEO Hypertension Pivotal Trial
Status:
SUSPENDED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company resources only allows adequate oversight for one pivotal trial at a time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
Detailed Description:
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.
All subjects are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during visits are:
* Office Cuff Blood Pressure
* Physical Assessment
* Subject Medications
* Serious adverse events
All subjects are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during visits are:
* Office Cuff Blood Pressure
* Physical Assessment
* 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?:
None
Is an FDA AA801 Violation?: