Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

Cyberonics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Congestive Heart Failure

Treatments: Device: Vagus Nerve Stimulation (VNS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01823887

C-01

Details and patient eligibility

About

The ANTHEM-HF 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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Left Sided Stimulation

Experimental group

Description:

Left cervical Vagus Nerve Stimulation (VNS)

Treatment:

Device: Vagus Nerve Stimulation (VNS)

Right Sided Stimulation

Experimental group

Description:

Right Cervical Vagus Nerve Stimulation (VNS)

Treatment:

Device: Vagus Nerve Stimulation (VNS)