Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
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.
Description
The primary aim of this study is to evaluate the accuracy of current wearable technology using the Apple Watch AFib History tool, relative to ambulatory electrocardiogram (ECG) monitoring using the Zio Patch, for quantifying AF burden after surgical ablation. AF burden will be measured as a weekly estimate, defined as the percentage of time in AF over the prior seven consecutive days. This assessment will occur at 3 months, 6 months, and 1 year postoperatively. This is a paired study design in which each subject will receive both the investigational device (Apple Watch) and reference device (…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 22 years of age or older * Documented or current history of atrial fibrillation (paroxysmal, persistent, or long-standing persistent) * Undergoing elective mitral valve surgery (repair or replacement) with concomitant surgical ablation using a Cox-Maze IV lesion set and left atrial appendage occlusion procedure, with and without concomitant tricuspid valve procedure (repair or replacement) * Use or access to Apple iPhone * Willing and able to provide informed consent and wear both the Apple Watch and Zio Patch at pre-specified intervals for the duration of the study peri…
Interventions
- DeviceApple Watch: AFib History
The Apple Watch AFib History feature uses PPG pulse rhythm data to detect and quantify the burden of atrial fibrillation.
- DeviceZio 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. LouisSt Louis, Missouri
- Cleveland ClinicCleveland, Ohio