Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05653583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-08
First Post:
2022-11-30
Brief Title:
Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
Sponsor:
Cala Health Inc
Organization:
Cala Health Inc
Study Overview
Official Title:
A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None