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ANTHEM-HFrEF Pivotal Study

NCT03425422 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

VITARIA System

Chronic stimulation of the right cervical vagus nerve

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425422 on ClinicalTrials.gov