Back to resultsBaroreflex Activation Therapy in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Barostim Neo System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- MultiMedica
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device group
Arm Description
Barostim Neo system
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in Systolic Blood Pressure
Change in systolic blood pressure at 6 months compared to baseline
Change in Diastolic Blood Pressure
Change in diastolic blood pressure at 6 months compared to baseline
Change in Heart Rate
Change in heart rate at 6 months compared to baseline
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.
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.
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.
Change in Left Ventricular Ejection Fraction (LVEF)
Change in LVEF at 6 months compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01484288
Brief Title
Baroreflex Activation Therapy in Heart Failure
Official Title
Baroreflex Activation Therapy in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CVRx, Inc.
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device group
Arm Type
Experimental
Arm Description
Barostim Neo system
Intervention Type
Device
Intervention Name(s)
Barostim Neo System
Other Intervention Name(s)
XR-1 System, Neo system
Intervention Description
Baroreflex Activation Therapy using the Barostim Neo System
Primary Outcome Measure Information:
Title
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
Description
Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline
Time Frame
6 months
Title
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)
Description
Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
Change in systolic blood pressure at 6 months compared to baseline
Time Frame
6 months
Title
Change in Diastolic Blood Pressure
Description
Change in diastolic blood pressure at 6 months compared to baseline
Time Frame
6 months
Title
Change in Heart Rate
Description
Change in heart rate at 6 months compared to baseline
Time Frame
6 months
Title
Change in Six-Minute Hall Walk
Description
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
Title
New York Heart Association (NYHA) Class
Description
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.
Time Frame
Six months
Title
Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)
Description
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.
Time Frame
Six months
Title
Change in Left Ventricular Ejection Fraction (LVEF)
Description
Change in LVEF at 6 months compared to baseline
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo G Gronda, MD, FESC
Organizational Affiliation
MultiMedica
Official's Role
Principal Investigator
Facility Information:
Facility Name
MultiMedica
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Baroreflex Activation Therapy in Heart Failure
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