Heart Failure
Conditions
Keywords
Systolic Heart Failure, Congestive Heart Failure, Reduced left ventricular ejection fraction, HFrEF
Brief summary
The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).
Detailed description
A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.
Interventions
DEVICEBAROSTIM NEO® System
Implant procedure
OTHERStandard of care medical managment therapy for heart failure
Standard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Sponsors
CVRx, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON. * 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 |
|---|---|---|
| Heart failure metric improvements from baseline | 12 months | To describe changes in measures compared to baseline. |
| System and procedure related adverse events | 6 months | To demonstrate the safety of the Neo system in a heart failure population. |
Countries
United States
Outcome results
None listed