Baroreflex Activation Therapy in Heart Failure

Heart Failure Clinical Trial

Official title:

Baroreflex Activation Therapy in Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484288
• Other study ID #: 360025
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2021
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Barostim Neo System
Baroreflex Activation Therapy using the Barostim Neo System

Locations

Country	Name	City	State
Italy	MultiMedica	Milan

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	6 months
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	6 months
Secondary	Change in Systolic Blood Pressure	Change in systolic blood pressure at 6 months compared to baseline	6 months
Secondary	Change in Diastolic Blood Pressure	Change in diastolic blood pressure at 6 months compared to baseline	6 months
Secondary	Change in Heart Rate	Change in heart rate at 6 months compared to baseline	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.	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.	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.	Six months
Secondary	Change in Left Ventricular Ejection Fraction (LVEF)	Change in LVEF at 6 months compared to baseline	Six months