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Smartwatch vs. implant: a Non-Invasive way to catch hidden heart rhythm problems?

NCT ID NCT06091514

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether a smartwatch can accurately detect atrial fibrillation (AF) in people at high risk, such as those who've had a stroke or have symptoms. Participants will wear the CS Medical Watch while also having an implantable loop recorder (ILR) in place, and the watch's readings will be compared to the ILR's ECG recordings. The goal is to see if the watch can serve as a reliable, non-invasive alternative for long-term AF monitoring.

What this could mean

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

Active substance
CS Medical Watch (a smartwatch using pulse plethysmography) compared with implantable loop recorders
What this could lead to
If accurate, this could offer a non-invasive alternative to implantable monitors for detecting atrial fibrillation, potentially reducing stroke risk in high-risk patients.
What could go wrong
The trial is early and small, and the smartwatch may not match the accuracy of implantable recorders. It also requires patients to wear the watch consistently.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Feb 2024

An estimate. Start dates often move.

Expected to finish

Feb 2026

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.

Ages

18 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: * Patient aged 18 years or more * Patient having signed free, informed, and written consent * Patient presenting one of the following situations : * Post-stroke or TIA patient with an already in place ILR * Patient with symptoms evocative of AF (e.g. increased heart rate, chest pain) with an already in place ILR * Post-PFO closure patient with an already in place ILR * Patient in sinus rhythm treated for the prevention of paroxysmal AF with an already in place ILR * Patient at high risk of AF (at the discretion of the investigator) with an already in place ILR * Patient with a period of risk of AF ≥ 3 months. Exclusion Criteria: * Patient under legal protection * Pregnant and/or breastfeeding women * Patient with pacemakers, or ICD * Patient with blood flow deficiency-related conditions * Patient with tattoo or injured skin on the wrist * Patient with tremors or otherwise unable to remain still for 15 minutes * Patient without two hands and sufficient fingers to complete the study.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

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