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Can closing a hole in the heart prevent future strokes? a long-term study seeks answers.

NCT ID NCT07724171

Knowledge-focused Sponsor: Yonsei University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tracks 400 people who had a procedure to close a patent foramen ovale (PFO), a small hole between the heart's upper chambers that can raise stroke risk. Researchers want to see how often strokes or mini-strokes return, whether a residual shunt persists, and what factors influence outcomes. Participants are followed for up to 10 years with regular heart imaging.

What this could mean

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

Active substance
percutaneous patent foramen ovale closure
What this could lead to
If successful, this could help identify which patients benefit most from PFO closure and how to reduce residual shunt and stroke recurrence.
What could go wrong
This is an observational registry, not a randomized trial, so it cannot prove cause and effect. Results may be limited by the single-center design and retrospective data.

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

Jun 2026

Expected to finish

May 2036

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

Consecutive adults who underwent percutaneous patent foramen ovale closure at a single tertiary referral center in Seoul, Republic of Korea. The retrospective cohort comprises patients treated between 2010 and March 2026 who had at least one post-procedural agitated saline transthoracic echocardiography. The prospective cohort comprises patients undergoing closure after institutional review board approval who provide written informed consent. The population reflects routine clinical practice, and treatment is not assigned by protocol.

Ages

19 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: 1. Age 19 years or older 2. Percutaneous patent foramen ovale closure 3. Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography 4. Prospective cohort: closure performed after institutional review board approval, with written informed consent Exclusion Criteria: 1. Atrial septal defect closure (defect other than patent foramen ovale) 2. Device embolization or device removal 3. Echocardiographic image quality inadequate for assessment of shunt 4. Prospective cohort: refusal of informed consent

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Ischemic Stroke patent foramen ovale stroke disorder transient ischemic attack

As listed by the trial registrant

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

Atrial fibrillation Cryptogenic stroke Patent foramen ovale Transient ischemic attack due to embolism

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

  • Yonsei University College of Medicine

    RECRUITING

    Seoul, South Korea

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