NCT07122947Recruiting
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 2 Jun 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Atrial fibrillation
- NCT number
- NCT07122947
What you commit to
- Study type: Observational
- Planned participants: 75
- From 2 Jun 2025 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant aortic valve replacement or coronary artery bypass graft
Other illness
- Presence of a cardiac pacemaker
- Personal or family history of adhesive skin allergies to adhesives or hydrogels
Lab values
- Heart failure with reduced ejection fraction (\<40%)
Other
- Tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Washington University School of Medicine in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.