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

NCT07122947 | Recruiting

• 1 other identifier: 25-458
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Wearable; Apple Watch; Atrial Fibrillation; Arrhythmia; Zio Patch; Ambulatory Rhythm Monitoring

Outcome Measures

Primary Outcomes (1)

• Accuracy of AF burden

  This will be measured by comparing the weekly AF burden estimates from the Apple Watch AF History feature to the Zio Patch ambulatory ECG monitoring device. Weekly AF burden is defined as the percentage of time in AF over the prior seven consecutive days and will be measured at 3 months, 6 months, and 1 year postoperatively.

  From enrollment to 1 year postoperatively

Interventions

Apple Watch: AFib History DEVICE

The Apple Watch AFib History feature uses PPG pulse rhythm data to detect and quantify the burden of atrial fibrillation.

Also known as: Apple Watch Series 10, Photoplethysmography (PPG) Pulse Rhythm Monitoring

Zio Patch DEVICE

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.

Also known as: iRhythm Zio Patch, Continuous Ambulatory ECG Monitoring

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>22 years) with a documented history of atrial fibrillation and mitral valve disease who undergo surgical ablation with a Cox-Maze IV concomitant to elective mitral valve surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Washington University School of Medicine: collaborator

Study Sites (2)

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Photoplethysmography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marc Gillinov, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Bakir, MD

CONTACT

216-312-4443; bakirn@ccf.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)