Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT01471860
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAROSTIM NEO System in the Treatment of Heart Failure
Sponsor:
CVRx, Inc.
Organization:
Study Overview
Official Title:
Neo Randomized Heart Failure Study
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
Detailed Description:
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.
During long-term follow-up, all participants are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
* Physical Assessment
* Subject Medications
* Serious adverse events
During long-term follow-up, all participants are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
* 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?:
True
Is an FDA AA801 Violation?: