NCT05653583

Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cala Health, Inc. · Industry
• Sex: All
• Age: 22 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Wrist Device	peripheral nerve stimulation via wrist-worn device
DEVICE	Ear Device	peripheral nerve stimulation via ear-worn device
DEVICE	Sham Device	Wrist-worn device that does not actually deliver stimulation

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-12-16
• Last updated: 2023-02-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study