Recruiting

Apple Watch vs. Zio Patch

Sponsor:

The Cleveland Clinic

Code:

NCT07122947

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Apple Watch: AFib History

Zio Patch

Study Details

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

Study ID

NCT07122947

Start date

Jun 2, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Interventions

Apple Watch: AFib History

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

Zio 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.

Primary outcome measure

  • Accuracy of AF burden [ Time Frame: From enrollment to 1 year postoperatively ]

Central Contacts and Locations

Central contacts

Nadia Bakir, MD

216-312-4443bakirn@ccf.org

Locations

Washington University School of Medicine in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Samantha Mulqueeny, RN

314-273-3905samantham@wustl.edu

Principal Investigator:

Ralph Damiano Jr., MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Nadia Bakir, MD

216-312-4443bakirn@ccf.org

Principal Investigator:

Marc Gillinov, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-08.