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OpenTrials
Completed

NCT Number: NCT01484288

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MultiMedica

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAROSTIM NEO System

Device

Baroreflex Activation Therapy using the Barostim Neo System

Other names: XR-1 System, Neo system

Primary outcomes

  1. Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)

    Time frame: 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)

    Time frame: 6 months

    Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 6 months

    Change in systolic blood pressure at 6 months compared to baseline

  2. Change in Diastolic Blood Pressure

    Time frame: 6 months

    Change in diastolic blood pressure at 6 months compared to baseline

  3. Change in Heart Rate

    Time frame: 6 months

    Change in heart rate at 6 months compared to baseline

  4. Change in Six-Minute Hall Walk

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: Six months

    Change in LVEF at 6 months compared to baseline

Sponsors and collaborators

Lead sponsor

CVRx, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Dec 2, 2011
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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