Baroreflex Activation Therapy in Heart Failure
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 |
---|---|---|
|
N/A |
Study Design
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:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Change in Systolic Blood Pressure [6 months]
Change in systolic blood pressure at 6 months compared to baseline
- Change in Diastolic Blood Pressure [6 months]
Change in diastolic blood pressure at 6 months compared to baseline
- 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.
- 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 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
Eligibility Criteria
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
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.- 360025
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
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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%
|
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)
|
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
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 |
egalle@cvrx.com |
- 360025