RecruitingNCT07122947

Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF

Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)

Sponsor

The Cleveland Clinic

Enrollment

75 participants

Start Date

Jun 2, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

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.

Eligibility

Min Age: 22 Years

Inclusion Criteria6

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 period
Willing and able to participate in long-term follow up including study visits and surveys

Exclusion Criteria6

Presence of a cardiac pacemaker
Heart failure with reduced ejection fraction (\<40%)
Concomitant aortic valve replacement or coronary artery bypass graft
Personal or family history of adhesive skin allergies to adhesives or hydrogels
Tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed
Pregnancy

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.