Baroreflex Activation Therapy in Heart Failure

CVRx

Status: Completed

Conditions: Heart Failure

Treatments: Device: Barostim Neo System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484288

360025

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Device group

Experimental group

Description:

Barostim Neo system

Treatment:

Device: Barostim Neo System