BAROSTIM NEO System in the Treatment of Heart Failure

Neo Randomized Heart Failure Study

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.

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

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.