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New study tests best way to prevent second stroke in seniors with a hole in the heart

NCT ID NCT07479147

Disease control Sponsor: Taichung Veterans General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at two ways to prevent another stroke in older adults who have a hole in the heart (PFO) and had a stroke from an unknown cause. One option is a procedure to close the hole, plus lifelong blood thinners. The other is taking blood thinners alone. Researchers will track which group has fewer repeat strokes or mini-strokes over several years. The study includes both new patients and data from past years.

What this could mean

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

Active substance
PFO closure device (Amplatzer occluder) and/or blood thinners (DOAC or antiplatelet)
What this could lead to
If successful, this could show that PFO closure is a safe and effective option for preventing another stroke in older adults, potentially changing treatment guidelines.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The study is still recruiting and won't finish until 2031. Risks include bleeding from blood thinners or complications from the closure procedure.

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 400 people

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

Started

Dec 2025

Expected to finish

Dec 2031

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

Patients with recent embolic stroke of undetermined source and patent foramen ovale (PFO)

Ages

18 to 90 years

Sex

Anyone

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 or his/her legal representative signs a written informed consent * Participants who have diagnosed as PFO related stroke * For patient aged 18-59: patient with high risk PFO feature or RoPE score ≥ 7 * For patient aged 60-90: patient with high risk PFO feature or RoPE score ≥ 4, must include cortical infarct Exclusion Criteria: * Follow-up less than 6 months * Extracardiac right-to-left shunt * Known stroke mechanism was diagnosed

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Conditions

The condition(s) this trial relates to.

intracranial embolism ischemic stroke patent foramen ovale stroke disorder

As listed by the trial registrant

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

Elderly Embolic stroke of undetermined source Ischemic stroke Patent foramen ovale (PFO)

How to take part

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

  1. The places running it

    3 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

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 100, Taiwan

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