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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
The Cleveland Clinic
Study ID
NCT07122947
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
75 participants (estimated)

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine in St. LouisSt LouisMissouri63110
Samantha Mulqueeny, RN
[email protected]
314-273-3905
Ralph Damiano Jr., MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Nadia Bakir, MD
[email protected]
216-312-4443
Marc Gillinov, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Washington University School of Medicine in St. Louis· St Louis, MOCleveland Clinic· Cleveland, OH

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