Baroreflex Activation Therapy in Heart Failure

Sponsor
CVRx, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01484288
Collaborator
(none)
12
1
1
40
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Barostim Neo System
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Baroreflex Activation Therapy in Heart Failure
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. Change in Systolic Blood Pressure [6 months]

      Change in systolic blood pressure at 6 months compared to baseline

    2. Change in Diastolic Blood Pressure [6 months]

      Change in diastolic blood pressure at 6 months compared to baseline

    3. Change in Heart Rate [6 months]

      Change in heart rate at 6 months compared to baseline

    4. 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.

    5. 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.

    6. 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.

    7. Change in Left Ventricular Ejection Fraction (LVEF) [Six months]

      Change in LVEF at 6 months compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MultiMedica Milan Italy

    Sponsors and Collaborators

    • CVRx, Inc.

    Investigators

    • Principal Investigator: Edoardo G Gronda, MD, FESC, MultiMedica

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CVRx, Inc.
    ClinicalTrials.gov Identifier:
    NCT01484288
    Other Study ID Numbers:
    • 360025
    First Posted:
    Dec 2, 2011
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Of the 12 subjects enrolled, 1 subject was a screen failure and was not implanted.
    Pre-assignment Detail
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Period Title: Overall Study
    STARTED 11
    COMPLETED 11
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Overall Participants 11
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    67
    (9)
    Sex: Female, Male (Count of Participants)
    Female
    3
    27.3%
    Male
    8
    72.7%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    10
    90.9%
    Black/African Descent
    1
    9.1%
    Region of Enrollment (Count of Participants)
    Italy
    11
    100%
    York Heart Association (NYHA) Class III (Count of Participants)
    Count of Participants [Participants]
    11
    100%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    26
    (5)
    Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    118
    (14)
    Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    70
    (9)
    Heart Rate (bpm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [bpm]
    72
    (8)
    Left Ventricular Ejection Fraction (LVEF) (Percentage of LVEF) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of LVEF]
    31
    (7)
    B-type natriuretic peptide (BNP) (pg/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pg/mL]
    314
    (307)
    6-Minute Hall Walk (Meters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Meters]
    304
    (50)
    Quality of Life (Minnesota Living with Heart Failure) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    33
    (30)

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [bursts/min]
    -13.8
    (1.4)
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [bursts/100 heartbeats]
    -22.5
    (2.5)
    3. Secondary Outcome
    Title Change in Systolic Blood Pressure
    Description Change in systolic blood pressure at 6 months compared to baseline
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [mmHg]
    0.2
    (4.6)
    4. Secondary Outcome
    Title Change in Diastolic Blood Pressure
    Description Change in diastolic blood pressure at 6 months compared to baseline
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [mmHg]
    -2.3
    (2.6)
    5. Secondary Outcome
    Title Change in Heart Rate
    Description Change in heart rate at 6 months compared to baseline
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [bpm]
    -0.2
    (3.0)
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [Meters]
    51.1
    (25.6)
    7. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    NYHA Class was not available for 1 patient at the 6-month timepoint.
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 10
    Class I
    9
    81.8%
    Class II
    1
    9.1%
    Class III
    0
    0%
    Class IV
    0
    0%
    8. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [units on a scale]
    -10.6
    (3.8)
    9. Secondary Outcome
    Title Change in Left Ventricular Ejection Fraction (LVEF)
    Description Change in LVEF at 6 months compared to baseline
    Time Frame Six months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    Measure Participants 11
    Mean (Standard Error) [percentage of LVEF]
    0.8
    (1.9)

    Adverse Events

    Time Frame 12 months
    Adverse Event Reporting Description
    Arm/Group Title Device Group
    Arm/Group Description Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
    All Cause Mortality
    Device Group
    Affected / at Risk (%) # Events
    Total 1/11 (9.1%)
    Serious Adverse Events
    Device Group
    Affected / at Risk (%) # Events
    Total 7/11 (63.6%)
    Cardiac disorders
    Acute decompensated heart failure 3/11 (27.3%) 4
    Gastrointestinal disorders
    Intestinal obstruction 1/11 (9.1%) 1
    Hepatobiliary disorders
    Gallstones 1/11 (9.1%) 1
    Infections and infestations
    Epididymo-orchitis 1/11 (9.1%) 1
    Nervous system disorders
    Tremor aggravated 1/11 (9.1%) 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Edema 2/11 (18.2%) 2
    Other (Not Including Serious) Adverse Events
    Device Group
    Affected / at Risk (%) # Events
    Total 3/11 (27.3%)
    Cardiac disorders
    supraventricular tachycardia 1/11 (9.1%) 1
    Endocrine disorders
    Diabetic foot ulcer 1/11 (9.1%) 2
    Vascular disorders
    Epistaxis 1/11 (9.1%) 5

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Vice President, Global Clinical Research
    Organization CVRx
    Phone 763-416-2876
    Email egalle@cvrx.com
    Responsible Party:
    CVRx, Inc.
    ClinicalTrials.gov Identifier:
    NCT01484288
    Other Study ID Numbers:
    • 360025
    First Posted:
    Dec 2, 2011
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021