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Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
Sponsor: The Cleveland Clinic
Summary
This is a prospective multicenter clinical study comparing the efficacy of the Apple Watch AFib History tool to the iRhythm Zio Patch monitoring device in quantifying atrial fibrillation (AF) burden after surgical ablation. Patients with AF and mitral valve (MV) disease who undergo a Cox-Maze IV procedure concomitant to MV surgery will be evaluated at serial timepoints for up to 1 year postoperatively. The trial will be conducted in the United States at the Cleveland Clinic in Cleveland, OH and at the Washington University School of Medicine in St. Louis, MO.
Official title: Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2025-06-02
Completion Date
2027-12-31
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Apple Watch: AFib History
The Apple Watch AFib History feature uses PPG pulse rhythm data to detect and quantify the burden of atrial fibrillation.
Zio Patch
The 14-day Zio Patch monitoring device (iRhythm Technologies, Inc., San Francisco, CA) uses continuous ambulatory ECG monitoring to quantify the burden of atrial fibrillation.
Locations (2)
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States