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Heart patch could spot silent stroke risk in elderly women

NCT ID NCT05444335

Diagnosis Sponsor: University of Maryland, Baltimore 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a wearable heart monitor (Zio patch) worn for two weeks can detect undiagnosed atrial fibrillation in women aged 70 and older. Atrial fibrillation is a common heart rhythm problem that raises stroke risk, especially in older women. The goal is to see how many women have this condition and whether screening leads to more use of stroke-preventing blood thinners.

What this could mean

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

Active substance
Zio patch wearable cardiac monitor
What this could lead to
If successful, this could show that widespread screening with a simple patch helps catch hidden atrial fibrillation in older women, potentially reducing their stroke risk.
What could go wrong
This is a small pilot study with only 120 participants, so results may not apply to all older women. The device may be uncomfortable or not worn correctly, and finding Afib does not guarantee that treatment will prevent strokes.

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.

Participants

About 120 people

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

Started

Jul 2023

Expected to finish

Dec 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

70 to 100 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Female sex 2. No previous diagnosis of atrial fibrillation 3. Age ≥70 years 4. CHA2DS2-VASc score ≥4 Exclusion Criteria: 1. Life expectancy \< 2 years 2. Dementia or other neurologic condition which would make outpatient follow-up difficult 3. CHA2DS2-VASc score ≤3 4. Any compliance issues - such as heavy alcohol/drug use that would impede follow up.

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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 new onset

Contacts and locations

Locations

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.