NCT03425422

ANTHEM-HFrEF Pivotal Study

Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 533 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.

Detailed description

ANTHEM-HFrEF is a multi-center, open-label, randomized controlled clinical trial with an adaptive design. Patients with symptomatic heart failure and reduced LVEF will be enrolled and randomized 2:1 to receive VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medical therapy alone (control arm). Subjects in the therapy arm will receive continuous, periodic VNS stimulation after surgery is completed, and will undergo visits for VNS up titration over a period of 3 months. Subjects in the control arm will also undergo scheduled visits at a similar frequency as the titration visits that are scheduled for subjects in the therapy arm. Data for safety and efficacy assessments will be collected for both study arms at 4 weeks post-randomization, every 3 months for the first 12 months, and every 4 months thereafter.

Conditions

• Heart Failure
• Heart Failure, Congestive
• Heart Failure, Systolic

Interventions

Type	Name	Description
DEVICE	VITARIA System	Chronic stimulation of the right cervical vagus nerve

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2018-02-07
• Last updated: 2023-10-10

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study