Compares two heart rhythm monitors in people with atrial fibrillation after surgery
Compares two heart monitors in people with atrial fibrillation after surgery.
Plain-language title generated from the registry record
Registry title: Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
Key facts
- Where
- Cleveland and St Louis, United StatesSee the 2 sites
Where in United States
- Cleveland ClinicCleveland, United StatesTaking people
- Washington University School of Medicine in St. LouisSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Cleveland Clinic
- Trial code
- NCT07122947
- Record updated
- 8 September 2026
- Original description
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.Read full original descriptionShow less
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
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.
Inclusion: 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: Concomitant aortic valve replacement or coronary artery bypass graft; Presence of a cardiac pacemaker; Personal or family history of adhesive skin allergies to adhesives or hydrogels; Heart failure with reduced ejection fraction (<40%); Tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed; Pregnancy.