Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT05266235
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
Sponsor:
Withings
Organization:
Study Overview
Official Title:
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2023-03
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:
QDA-UE
Brief Summary:
The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.
Detailed Description:
Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: