Verily Watch Cardio (AF and ECG) Study
NCT06041373 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2023-12-22
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
Interventions
- 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.
Sponsors & Collaborators
-
Verily Life Sciences LLC
lead INDUSTRY
Principal Investigators
-
Hamid Ghanbari, MD · Verily Life Sciences
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-30
- Primary Completion
- 2024-07-31
- Completion
- 2024-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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