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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device group | Experimental | Barostim Neo system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barostim Neo System | Device | Baroreflex Activation Therapy using the Barostim Neo System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Change in systolic blood pressure at 6 months compared to baseline | 6 months |
| Change in Diastolic Blood Pressure | Change in diastolic blood pressure at 6 months compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edoardo G Gronda, MD, FESC | MultiMedica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MultiMedica | Milan | Italy |
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Of the 12 subjects enrolled, 1 subject was a screen failure and was not implanted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Group | Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Group | Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | bursts/min | 6 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Group | Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute decompensated heart failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Global Clinical Research | CVRx | 763-416-2876 | egalle@cvrx.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months |
| Change in Heart Rate | Change in heart rate at 6 months compared to baseline | 6 months |
| 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. | 6 months |
| 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. | Six months |
| 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. | Six months |
| Change in Left Ventricular Ejection Fraction (LVEF) | Change in LVEF at 6 months compared to baseline | Six months |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| York Heart Association (NYHA) Class III | 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. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Mean | Standard Deviation | bpm |
|
| Left Ventricular Ejection Fraction (LVEF) | Mean | Standard Deviation | Percentage of LVEF |
|
| B-type natriuretic peptide (BNP) | Mean | Standard Deviation | pg/mL |
|
| 6-Minute Hall Walk | 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. | Mean | Standard Deviation | Meters |
|
| Quality of Life (Minnesota Living with Heart Failure) | 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. | Mean | Standard Deviation | units on a scale |
|
|
| 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 | Posted | Mean | Standard Error | bursts/100 heartbeats | 6 months |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Change in systolic blood pressure at 6 months compared to baseline | Posted | Mean | Standard Error | mmHg | 6 months |
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure at 6 months compared to baseline | Posted | Mean | Standard Error | mmHg | 6 months |
|
|
|
| Secondary | Change in Heart Rate | Change in heart rate at 6 months compared to baseline | Posted | Mean | Standard Error | bpm | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Error | Meters | 6 months |
|
|
|
| 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. | NYHA Class was not available for 1 patient at the 6-month timepoint. | Posted | Count of Participants | Participants | Six months |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Six months |
|
|
|
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | Change in LVEF at 6 months compared to baseline | Posted | Mean | Standard Error | percentage of LVEF | Six months |
|
|
|
| 1 |
| 11 |
| 7 |
| 11 |
| 3 |
| 11 |
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Gallstones | Hepatobiliary disorders | Systematic Assessment |
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| Epididymo-orchitis | Infections and infestations | Systematic Assessment |
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| Tremor aggravated | Nervous system disorders | Systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diabetic foot ulcer | Endocrine disorders | Systematic Assessment |
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| Epistaxis | Vascular disorders | Systematic Assessment |
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| Class IV |
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