BAROSTIM® Hope for Heart Failure Study

Barostim HOPE4HF Study

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).

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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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.

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.