BAROSTIM NEO System in the Treatment of Heart Failure

Study Overview
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Brief Summary
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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
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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

Official Title
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Neo Randomized Heart Failure Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: BAROSTIM NEO System
* Drug: Medical Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device and Medical Management<br>Medical Management, to be determined by the participant's physician, described as: Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling. Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications. Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study. | Device: BAROSTIM NEO System<br> <br> * Other names: Neo System;Drug: Medical Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System | 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. | For the duration of the study, up to 5 years. |