Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.

Detailed Description
-----------------
Summary: The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.

Official Title
-----------------
Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Barostim™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry. Indications: The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines. Contraindications: Bilateral carotid bifurcations located above the level of the mandible Baroreflex failure or autonomic neuropathy Uncontrolled, symptomatic cardiac bradyarrhythmias Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50% Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation Known allergy to silicone or titanium
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Barostim™ System|Implantation of the Barostim™ System|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious adverse events related to the system or implant procedure | Serious adverse events related to the system or implant procedure through 36 months post-implant | 36 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of heart failure hospitalizations | Number of heart failure hospitalizations through 36 months post-implant | 36 months post-implant | 
| Duration of heart failure hospitalizations | Duration of heart failure hospitalizations through 36 months post-implant | 36 months post-implant | 
| Change NYHA Classification | Changes in NYHA Classification through 36 months post-implant | 36 months post-implant | 
| Change in NT-proBNP | Changes in NT-proBNP through 36 months post-implant | 36 months post-implant | 
| Change in LVEF | Changes in LVEF through 36 months post-implant | 36 months post-implant | 
| Change in Six Minute Hall Walk | Changes in Six Minute Hall Walk distance through 36 months post-implant | 36 months post-implant |