Apple Watch vs Zio Patch for tracking AF burden after mitral valve surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.