Heart Failure
Conditions
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.
Interventions
DEVICEBarostim Neo System
Baroreflex Activation Therapy using the Barostim Neo System
Sponsors
CVRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate | 6 months | Change in heart rate at 6 months compared to baseline |
| 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 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. |
| Change in Left Ventricular Ejection Fraction (LVEF) | Six months | Change in LVEF 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 Diastolic Blood Pressure | 6 months | Change in diastolic blood pressure at 6 months compared to baseline |
Countries
Italy
Participant flow
Recruitment details
Of the 12 subjects enrolled, 1 subject was a screen failure and was not implanted.
Participants by arm
| Arm | Count |
|---|---|
| Device Group Barostim Neo system
Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Device Group |
|---|---|
| 6-Minute Hall Walk | 304 Meters STANDARD_DEVIATION 50 |
| Age, Continuous | 67 Years STANDARD_DEVIATION 9 |
| Body Mass Index (BMI) | 26 kg/m^2 STANDARD_DEVIATION 5 |
| B-type natriuretic peptide (BNP) | 314 pg/mL STANDARD_DEVIATION 307 |
| Diastolic Blood Pressure | 70 mmHg STANDARD_DEVIATION 9 |
| Heart Rate | 72 bpm STANDARD_DEVIATION 8 |
| Left Ventricular Ejection Fraction (LVEF) | 31 Percentage of LVEF STANDARD_DEVIATION 7 |
| Quality of Life (Minnesota Living with Heart Failure) | 33 units on a scale STANDARD_DEVIATION 30 |
| Race/Ethnicity, Customized Black/African Descent | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 10 Participants |
| Region of Enrollment Italy | 11 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
| Systolic Blood Pressure | 118 mmHg STANDARD_DEVIATION 14 |
| York Heart Association (NYHA) Class III | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 3 / 11 |
| serious Total, serious adverse events | 7 / 11 |
Outcome results
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats) | -22.5 bursts/100 heartbeats | Standard Error 2.5 |
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min) | -13.8 bursts/min | Standard Error 1.4 |
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Change in Diastolic Blood Pressure | -2.3 mmHg | Standard Error 2.6 |
Secondary
Change in Heart Rate
Change in heart rate at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Change in Heart Rate | -0.2 bpm | Standard Error 3 |
Secondary
Change in Left Ventricular Ejection Fraction (LVEF)
Change in LVEF at 6 months compared to baseline
Time frame: Six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Change in Left Ventricular Ejection Fraction (LVEF) | 0.8 percentage of LVEF | Standard Error 1.9 |
Secondary
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.
Time frame: Six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire) | -10.6 units on a scale | Standard Error 3.8 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Change in Six-Minute Hall Walk | 51.1 Meters | Standard Error 25.6 |
Secondary
Change in Systolic Blood Pressure
Change in systolic blood pressure at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group | Change in Systolic Blood Pressure | 0.2 mmHg | Standard Error 4.6 |
Secondary
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.
Time frame: Six months
Population: NYHA Class was not available for 1 patient at the 6-month timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group | New York Heart Association (NYHA) Class | Class I | 9 Participants |
| Device Group | New York Heart Association (NYHA) Class | Class II | 1 Participants |
| Device Group | New York Heart Association (NYHA) Class | Class III | 0 Participants |
| Device Group | New York Heart Association (NYHA) Class | Class IV | 0 Participants |