Barostim HOPE4HF (Hope for Heart Failure) Study
The purpose of this research study is to show whether the Neo system is safe and works in people with heart failure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Barostim HOPE4HF Study|
- Heart failure metric improvements from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]To describe changes in measures compared to baseline.
- System and procedure related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To demonstrate the safety of the Neo system in a heart failure population.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Device Group
Barostim Neo system
Device: Barostim Neo system
Patients will be implanted with the Neo system.
Other Name: Neo system
No Intervention: Medical Management Group
Medical management therapy only
A prospective, randomized study describing the safety and efficacy of the Neo system in approximately 60 heart failure subjects with a left ventricular ejection fraction equal or less than 35 percent.
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