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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether an Apple Watch can reliably monitor and measure the burden of atrial fibrillation (AFib) — how much of the time a person's heart is in an irregular rhythm — after they have had surgical treatment (called the Cox-Maze procedure) to correct AFib. **You may be eligible if...** - You are 22 years or older - You have a documented history of atrial fibrillation - You are scheduled to have mitral valve surgery along with a surgical ablation procedure (Cox-Maze IV) to treat your AFib - You are having your left atrial appendage closed off during the same surgery **You may NOT be eligible if...** - You are having an emergency (non-elective) surgery - You already have a pacemaker or implanted cardiac device that might interfere - You are not able or willing to wear the Apple Watch as required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Louis

St Louis, Missouri, United States

Cleveland Clinic

Cleveland, Ohio, United States

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NCT07122947


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