Trial Outcomes & Findings for Baroreflex Activation Therapy in Heart Failure (NCT NCT01484288)

NCT ID: NCT01484288

Last Updated: 2021-08-26

Results Overview

Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-08-26

Participant Flow

Of the 12 subjects enrolled, 1 subject was a screen failure and was not implanted.

Participant milestones

Measure	Device Group Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baroreflex Activation Therapy in Heart Failure

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 6 months

Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)	-13.8 bursts/min Standard Error 1.4

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)	-22.5 bursts/100 heartbeats Standard Error 2.5

SECONDARY outcome

Timeframe: 6 months

Change in systolic blood pressure at 6 months compared to baseline

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Change in Systolic Blood Pressure	0.2 mmHg Standard Error 4.6

SECONDARY outcome

Timeframe: 6 months

Change in diastolic blood pressure at 6 months compared to baseline

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Change in Diastolic Blood Pressure	-2.3 mmHg Standard Error 2.6

SECONDARY outcome

Timeframe: 6 months

Change in heart rate at 6 months compared to baseline

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Change in Heart Rate	-0.2 bpm Standard Error 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Change in Six-Minute Hall Walk	51.1 Meters Standard Error 25.6

SECONDARY outcome

Timeframe: Six months

Population: NYHA Class was not available for 1 patient at the 6-month timepoint.

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.

Outcome measures

Measure	Device Group n=10 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
New York Heart Association (NYHA) Class Class I	9 Participants
New York Heart Association (NYHA) Class Class II	1 Participants
New York Heart Association (NYHA) Class Class III	0 Participants
New York Heart Association (NYHA) Class Class IV	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)	-10.6 units on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: Six months

Change in LVEF at 6 months compared to baseline

Outcome measures

Measure	Device Group n=11 Participants Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Change in Left Ventricular Ejection Fraction (LVEF)	0.8 percentage of LVEF Standard Error 1.9

Adverse Events

Device Group

Serious events: 7 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Device Group n=11 participants at risk Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Cardiac disorders Acute decompensated heart failure	27.3% 3/11 • Number of events 4 • 12 months
Gastrointestinal disorders Intestinal obstruction	9.1% 1/11 • Number of events 1 • 12 months
Hepatobiliary disorders Gallstones	9.1% 1/11 • Number of events 1 • 12 months
Infections and infestations Epididymo-orchitis	9.1% 1/11 • Number of events 1 • 12 months
Nervous system disorders Tremor aggravated	9.1% 1/11 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	18.2% 2/11 • Number of events 2 • 12 months

Other adverse events

Measure	Device Group n=11 participants at risk Barostim Neo system Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System
Cardiac disorders supraventricular tachycardia	9.1% 1/11 • Number of events 1 • 12 months
Endocrine disorders Diabetic foot ulcer	9.1% 1/11 • Number of events 2 • 12 months
Vascular disorders Epistaxis	9.1% 1/11 • Number of events 5 • 12 months

Additional Information

Vice President, Global Clinical Research

CVRx

Phone: 763-416-2876

Email: egalle@cvrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place