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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
peripheral nerve stimulation via wrist-worn device
peripheral nerve stimulation via ear-worn device
Wrist-worn device that does not actually deliver stimulation
Mayo Clinic
Rochester, Minnesota, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Percentage of time spent in AF during the 4-week treatment period compared to the 2-week run-in period (prior to treatment) for AF episodes >= 30 seconds duration
Time frame: 6 weeks
Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period
Time frame: 6 weeks
Time to first recurrence of symptomatic AF during treatment period compared to run-in period
Time frame: 6 weeks
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Time frame: 6 weeks
Number of AF episodes lasting >= 5.5 hours
Time frame: 6 weeks
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
Time frame: 6 weeks
Atrial Fibrillation Effect on Quality of Life (AFEQL) score at the end of the treatment period compared to end of the run-in period
Time frame: 6 weeks
Compliance to per-protocol therapy measured by the percentage of full and partial therapy sessions delivered relative to total sessions required per-protocol
Time frame: 6 weeks
Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions
Time frame: 6 weeks
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