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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wrist Device | Active Comparator | Twice daily stimulation sessions during the 4-week treatment period |
|
| Ear Device | Active Comparator | Twice daily stimulation sessions during the 4-week treatment period |
|
| Sham Device | Sham Comparator | Twice daily "stimulation" sessions during the 4-week treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wrist Device | Device | peripheral nerve stimulation via wrist-worn device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period | 6 weeks | |
| Time to first recurrence of symptomatic AF during treatment period compared to run-in period | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of AF-related emergency visits | 6 weeks | |
| Number of AF-related in-patient hospitalizations | 6 weeks | |
| Number of cardioversion procedures |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahrose Aratia | Contact | 6506515296 | shahrose@calahealth.com | |
| Melissa Nishihama | Contact | 6506515296 | melissa@calahealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
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| Ear Device |
| Device |
peripheral nerve stimulation via ear-worn device |
|
| Sham Device | Device | Wrist-worn device that does not actually deliver stimulation |
|
| Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration) | 6 weeks |
| Number of AF episodes lasting >= 5.5 hours | 6 weeks |
| Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions | 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 | 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 | 6 weeks |
| Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions | 6 weeks |
| 6 weeks |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |