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Clinical Trial NCT07122947 (STARBURST-AF) for Atrial Fibrillation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF (STARBURST-AF) 75

Recruiting
Clinical Trial NCT07122947 (STARBURST-AF) is an observational study for Atrial Fibrillation that is recruiting. It started on 2 June 2025 with plans to enroll 75 participants. Led by The Cleveland Clinic, it is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 14 August 2025.
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...Show More
Detailed Description
The primary aim of this study is to evaluate the accuracy of current wearable technology using the Apple Watch AFib History tool, relative to ambulatory electrocardiogram (ECG) monitoring using the Zio Patch, for quantifying AF burden after surgical ablation. AF burden will be measured as a weekly estimate, defined as the percentage of time in AF over the prior seven consecutive days. This assessment will occur at 3 ...Show More
Official Title

Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)

Conditions
Atrial Fibrillation
Other Study IDs
  • STARBURST-AF
  • 25-458
NCT ID Number
NCT07122947
Start Date (Actual)
2025-06-02
Last Update Posted
2025-08-14
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
75
Study Type
Observational
Status
Recruiting
Keywords
Wearable
Apple Watch
Atrial Fibrillation
Arrhythmia
Zio Patch
Ambulatory Rhythm Monitoring
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
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 Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
22 Years
Eligible Sexes
All
  • 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

  • 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
The Cleveland Clinic logoThe Cleveland Clinic
Washington University School of Medicine logoWashington University School of Medicine462 active studies to explore
Study Responsible Party
Marc Gillinov, MD, Principal Investigator, Principal Investigator, The Cleveland Clinic
Study Central Contact
Contact: Nadia Bakir, MD, 216-312-4443, [email protected]
2 Study Locations in 1 Countries

Missouri

Washington University School of Medicine in St. Louis, St Louis, Missouri, 63110, United States
Samantha Mulqueeny, RN, Contact, 314-273-3905, [email protected]
Ralph Damiano Jr., MD, Principal Investigator
Recruiting

Ohio

Cleveland Clinic, Cleveland, Ohio, 44195, United States
Nadia Bakir, MD, Contact, 216-312-4443, [email protected]
Marc Gillinov, MD, Principal Investigator
Recruiting