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Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

Congestive Heart Failure Clinical Trial

Official title:
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03163030
Study type Interventional
Source LivaNova
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date December 2021
View Details
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