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Clinical Trial Summary

This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.


Clinical Trial Description

Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02545582
Study type Observational [Patient Registry]
Source Cyberonics, Inc.
Contact
Status Suspended
Phase N/A
Start date August 2015
Completion date December 2019

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