Baroreflex Activation Therapy in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Barostim Neo System

• Registration Number: NCT01484288
• Lead Sponsor: CVRx, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Primary Completion: 2013-07
• Study Completion: 2015-03
• Results First Submitted: 2021-07-12
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device group	Barostim Neo System	Barostim Neo system

Primary Outcome Measures

Name	Time	Method
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)	6 months	Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)	6 months	Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline

Secondary Outcome Measures

Name	Time	Method
Change in Six-Minute Hall Walk	6 months	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.
Change in Left Ventricular Ejection Fraction (LVEF)	Six months	Change in LVEF at 6 months compared to baseline
Change in Heart Rate	6 months	Change in heart rate at 6 months compared to baseline
Change in Diastolic Blood Pressure	6 months	Change in diastolic blood pressure at 6 months compared to baseline
New York Heart Association (NYHA) Class	Six months	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.
Change in Systolic Blood Pressure	6 months	Change in systolic blood pressure at 6 months compared to baseline
Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)	Six months	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.

Trial Locations

Locations (1)

MultiMedica; 🇮🇹 Milan, Italy