Baroreflex Activation Therapy in Heart Failure

CVRx, Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Barostim Neo SystemDEVICE

Baroreflex Activation Therapy using the Barostim Neo System

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

MultiMedica

Milan, Italy

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 6 months

Secondary Outcomes

Change in Systolic Blood Pressure

Change in systolic blood pressure at 6 months compared to baseline

Time frame: 6 months

Change in Diastolic Blood Pressure

Change in diastolic blood pressure at 6 months compared to baseline

Time frame: 6 months

Change in Heart Rate

Change in heart rate at 6 months compared to baseline

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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