Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622265
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
WHOOP ECG Software Performance Assessment Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-phase Prospective Multicenter Non-interventional Pre-market Non-randomized Open-label Study to Evaluate the Clinical Performance of the WHOOP ECG Feature
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates
Detailed Description:
Atrial fibrillation Afib is the most common cardiac arrhythmia in the United States affecting up to one in four individuals across the lifespan and is associated with substantial morbidity and mortality Fifteen percent of strokes in the United States are attributable to Afib and nearly 20 of these occur in individuals with no prior Afib history Because Afib is often paroxysmal one-time screening is unlikely to capture those at risk Thus there has been an increasing interest in leveraging monitoring for Afib via wearable devices which provide a novel method to monitor Afib and determine the burden of Afib in the general population
The primary objective of this study is to assess the sensitivity and specificity of the investigation device WHOOP ECG Feature for the detection of Afib as compared to a gold-standard reference 12-Lead ECG Holter Device
The primary objective of this study is to assess the sensitivity and specificity of the investigation device WHOOP ECG Feature for the detection of Afib as compared to a gold-standard reference 12-Lead ECG Holter Device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None