Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
Recruiting · NCT07122947 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Apple Watch: AFib HistoryZio Patch
What this trial is about
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.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed across 2 US states.
- Washington University School of Medicine in St. Louis - St Louis, Missouri, United States
- Cleveland Clinic - Cleveland, Ohio, United States