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Could a simple 14-day heart monitor patch prevent strokes in at-risk seniors?

NCT ID NCT06953778

Prevention Sponsor: VA Office of Research and Development 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study investigates whether screening older veterans (age 65 and older) who have a higher risk of atrial fibrillation—a condition where the heart beats irregularly—can reduce their chances of stroke, heart failure, or death. Participants selected for screening wear a small, waterproof patch (Zio XT) that records their heart rhythm for up to 14 days. The results are shared with their doctors, who may then prescribe blood thinners if atrial fibrillation is detected. The study compares outcomes between those screened and those receiving usual care to see if early detection makes a difference.

What this could mean

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

Active substance
Zio XT Patch (wearable heart monitor)
What this could lead to
If successful, this could show that widespread screening for hidden atrial fibrillation in older adults reduces strokes and saves lives.
What could go wrong
Screening may detect harmless irregularities, leading to unnecessary treatment and bleeding risks. The trial is large but observational in design, so results may not prove cause and effect.

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 24,060 people

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

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

65 years and older

Sex

Anyone

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: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, age \>=65 years 2. CHA2DS2-Vasc score \>=3. The score is comprised of age (2 points for 75, 1 point for 65-74), sex (1 point for female), history of stroke, TIA, or systemic embolism (2 points), and history of heart failure, hypertension, vascular disease (including MI, peripheral artery disease, or aortic plaque), or diabetes (1 point each). Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current use of anticoagulation 2. Diagnosis of AF (from administrative records or per patient during consent) 3. Cardio-thoracic surgery in the prior 3 months 4. Presence of pacemaker, implantable defibrillator, or implanted cardiac monitor 5. Clinically significant allergy to adhesives, as reported by the patient during screening for trial enrollment 6. Planned use of a brain or spinal-cord stimulator, TENS unit, or MRI scan during the period when the Zio Patch will be worn

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Ischemic Stroke

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

    1 site. 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

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207, United States

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