NCT06622265

WHOOP ECG Software Performance Assessment Study

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
• Phase: —
• Study type: Observational
• Enrollment: 540 (actual)
• Sponsor: Whoop Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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).

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DEVICE	Electrocardiogram recording	ECG recording with investigational device

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2024-10-02
• Last updated: 2024-10-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study