NCT06041373

Verily Watch Cardio (AF and ECG) Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Verily Life Sciences LLC · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Verily Watch Cardio	The Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses.
DEVICE	iRhythm Zio monitor	The iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days.
DEVICE	Schiller CARDIOVIT FT-1	The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-07-01
• Completion: 2024-11-01
• First posted: 2023-09-18
• Last updated: 2023-12-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study