Heart Failure
Conditions
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
Interventions
DEVICEBAROSTIM NEO System
DRUGMedical Management
Sponsors
CVRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Actively participating in the Neo Randomized Heart Failure Study. * Have signed a revised approved informed consent form for continued participation in this study.
Exclusion criteria
* Treating physician decision that the subject should not continue with therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System | For the duration of the study, up to 5 years. | Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System. |
Countries
Canada, France, Germany, Italy
Outcome results
None listed