Baroreflex Activation Therapy in Heart Failure

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.

Official Title
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Baroreflex Activation Therapy in Heart Failure

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: Age at least 21 years Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks Exclusion Criteria: Significant carotid plaque or stenosis Known or suspected baroreflex failure or autonomic neuropathy Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months Heart failure secondary to a reversible condition

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 group<br>Barostim Neo system | Device: Barostim Neo System<br>* Baroreflex Activation Therapy using the Barostim Neo System<br>* Other names: Neo system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min) | Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline | 6 months | 
| Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats) | Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Change in systolic blood pressure at 6 months compared to baseline | 6 months | 
| Change in Diastolic Blood Pressure | Change in diastolic blood pressure at 6 months compared to baseline | 6 months | 
| Change in Heart Rate | Change in heart rate at 6 months compared to baseline | 6 months | 
| Change in Six-Minute Hall Walk | Change in six-minute hall walk distance at 6 months compared to baseline. The 6-Minute Hall Walk test is a measure of physical function by measuring the distance a patient can walk in a 6-minute time period. | 6 months | 
| New York Heart Association (NYHA) Class | Number of patients with NYHA Class I-IV at 6 months. NYHA classification places patients in one of four categories based on how much they are limited during physical activity, where Class I indicates no limitation of physical activity and Class IV indicates the patient is unable to carry on any physical activity without discomfort. The patient has symptoms of heart failure at rest, and if any physical activity is undertaken, discomfort increases. | Six months | 
| Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire) | Change in Quality of Life as measured by the Minnesota Living with Heart Failure Questionnaire at 6 months compared to baseline. The Minnesota Living with Heart Failure Questionnaire is a 21-item questionnaire designed as a measure of heart failure, as indicated by its adverse effects on patients' lives. Each item is scored in a 6-point Likert Scale (0 to 5); therefore, the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. | Six months | 
| Change in Left Ventricular Ejection Fraction (LVEF) | Change in LVEF at 6 months compared to baseline | Six months |