Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

Cyberonics

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: Vagus Nerve Stimulation (VNS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03163030

C-04

Details and patient eligibility

About

The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and mid-range ejection fraction.

Full description

Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Therapy

Experimental group

Description:

Right Cervical Vagus Nerve Stimulation (VNS)

Treatment:

Device: Vagus Nerve Stimulation (VNS)