Trials / Unknown
UnknownNCT01471860
BAROSTIM NEO System in the Treatment of Heart Failure
Neo Randomized Heart Failure Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- CVRx, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BAROSTIM NEO System | |
| DRUG | Medical Management |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2014-09-01
- Completion
- 2021-08-11
- First posted
- 2011-11-16
- Last updated
- 2019-11-04
Locations
30 sites across 4 countries: Canada, France, Germany, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01471860. Inclusion in this directory is not an endorsement.