BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction

Study Overview
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Brief Summary
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The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with reduced ejection fraction (HFrEF).

Detailed Description
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Summary: The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry. Eligibility: Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy. The contraindications are: 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 to be greater than 50% Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation Objectives: To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline: New York Heart Association (NYHA) Class Six Minute Hall Walk Echocardiogram measures Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C). Evaluate health care utilization over follow-up, such as heart failure hospitalizations. Describe device programming and utilization

Official Title
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BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Barostim Neo™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy Subject has been implanted with the BAROSTIM NEO System in the past 30 days Subject has signed an Ethics Committee approved informed consent form Exclusion Criteria: 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 to be greater than 50% Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Barostim Neo™ System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in New York Heart Association Functional Classification at 6 months Post-Implant | To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification. | Baseline, 6 months post-implant | 
| Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant | To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance. | Baseline, 6 months post-implant | 
| Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant | To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index. | Baseline, 6 months post-implant | 
| Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) | To demonstrate that that treatment with BAROSTIM NEO improves biomarker results. | Baseline, 6 months post-implant | 
| Number of Hospitalizations over Follow-Up | To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations. | 12 months post-implant |