Actively Recruiting
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
Led by The Cleveland Clinic · Updated on 2025-08-14
75
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- May have concomitant tricuspid valve procedure (repair or replacement)
- Use or access to Apple iPhone
- Willing and able to provide informed consent
- Willing and able to wear both the Apple Watch and Zio Patch at specified intervals for the study duration
- Willing and able to participate in long-term follow-up including study visits and surveys
You will not qualify if you...
- Presence of a cardiac pacemaker
- Heart failure with reduced ejection fraction (<40%)
- Undergoing concomitant aortic valve replacement or coronary artery bypass graft
- Personal or family history of adhesive skin allergies to adhesives or hydrogels
- Tattoos on the skin of the wrist or forearm where the Apple Watch will be worn
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
N
Nadia Bakir, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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