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Apple watch vs. medical monitor: which better detects hidden heart rhythm problems?

NCT ID NCT07122947

Knowledge-focused Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study tests whether the Apple Watch's AFib History feature can accurately measure the amount of time spent in atrial fibrillation after a type of heart surgery called the Cox-Maze IV procedure. Researchers will compare the watch's readings to those from a standard medical device, the Zio Patch, which records the heart's rhythm continuously for 14 days. About 75 adults with atrial fibrillation who are having mitral valve surgery along with the maze procedure will wear both devices at 3, 6, and 12 months after surgery. The goal is to see if the watch can reliably detect hidden or silent episodes of irregular heartbeat, which could make follow-up care easier for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Apple Watch AFib History feature and Zio Patch continuous ECG monitor
What this could lead to
If the Apple Watch proves accurate, patients could monitor their heart rhythm at home after surgery, reducing the need for repeated clinic visits and improving long-term care.
What could go wrong
The trial is small and early, and the Apple Watch may not match the Zio Patch's precision. Also, the watch requires an iPhone, which may limit who can use it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients (\>22 years) with a documented history of atrial fibrillation and mitral valve disease who undergo surgical ablation with a Cox-Maze IV concomitant to elective mitral valve surgery.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Washington University School of Medicine in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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