Baroreflex Activation Therapy in Heart Failure

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Barostim Neo System

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Multimedica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device group; Barostim Neo system	Device: Barostim Neo System; Baroreflex Activation Therapy using the Barostim Neo System; Other Names: XR-1 System; Neo system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CVRx, Inc.
• Investigators: Principal Investigator: Edoardo G Gronda, MD, FESC, Multimedica

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 360025

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes