Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

Status Not yet recruiting

Clinical Trial Summary

This is a three-arm, single-blinded, randomized, sham-controlled, nonsignificant risk study to assess the feasibility of reducing Atrial Fibrillation burden with peripheral nerve stimulation. The three arms include treatment with a wrist-worn neuromodulation ("wrist device"), treatment with an ear-worn neuromodulation device ("ear device") and sham stimulation with wrist-worn device that does not actually deliver stimulation ("sham device"). ECG patches will be worn on the chest to measure AF episode onset and duration ("ECG Patch"). Additionally, a wrist-worn monitoring device will be used for the measurement of heart rate (HR), heart rate variability (HRV), and other biomarkers ("Cardiac Measurement Device (CMD)"). Finally, subjects will track AF episode onset, duration, and symptom type in an AF diary.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Atrial Fibrillation

Clinical Trial Details

NCT number	NCT05653583
Study type	Interventional
Source	Cala Health, Inc.
Contact	Shahrose Aratia
Phone	6506515296
Email	shahrose@calahealth.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2023
Completion date	December 2023

View Details

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