Apple Watch vs Zio Patch for tracking AF burden after mitral valve surgery
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
This project will test whether the Apple Watch AFib History tool can track atrial fibrillation burden as accurately as the Zio Patch in adults who have had mitral valve surgery with a Cox‑Maze IV ablation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (St Louis, Missouri and 1 other locations) |
| Trial ID | NCT07122947 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter paired-design study will enroll adults aged 22 and older with documented atrial fibrillation undergoing elective mitral valve surgery with concomitant Cox‑Maze IV ablation. Each participant will wear an Apple Watch using the AFib History tool and concurrently wear a Zio Patch ambulatory ECG, with weekly AF burden defined as percent time in AF over the prior seven days. Measurements will be compared at 3 months, 6 months, and 12 months postoperatively, and participants will complete PROMIS-10, MacNew, and AFSS questionnaires at baseline and follow-up. The study is conducted at the Cleveland Clinic (Cleveland, OH) and Washington University School of Medicine (St. Louis, MO).
Who should consider this trial
Good fit: Ideal candidates are adults ≥22 with a history of AF undergoing elective mitral valve surgery with concomitant Cox‑Maze IV ablation who have access to an iPhone and can attend follow-up visits in Cleveland or St. Louis.
Not a fit: Patients with implanted pacemakers, heart failure with ejection fraction under 40%, those undergoing concomitant CABG or aortic valve replacement, or those unable to use an iPhone or tolerate adhesive monitors are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could use a widely available wearable to monitor AF burden at home and reduce the need for repeated ambulatory ECG monitoring.
How similar studies have performed: Prior work has shown wearables can detect AF episodes, but few studies have validated Apple Watch AFib History against continuous ambulatory ECG for quantifying AF burden after surgical ablation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
St Louis, Missouri and 1 other locations
- Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Marc Gillinov, MD — The Cleveland Clinic
- Study coordinator: Nadia Bakir, MD
- Email: bakirn@ccf.org
- Phone: 216-312-4443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.