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Heart-Device study aims to stop strokes in patients with a hole in the heart

NCT ID NCT05529901

Disease control Sponsor: W.L.Gore & Associates 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking how well a device called the GORE® CARDIOFORM Septal Occluder works and how safe it is for people who have had a stroke caused by a hole in the heart (PFO). Researchers will follow 300 patients in Japan for 12 months after the device is implanted. The goal is to see if the device closes the hole and helps prevent future strokes.

What this could mean

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

Active substance
GORE® CARDIOFORM Septal Occluder (a device implanted to close a hole in the heart)
What this could lead to
If successful, this could confirm that the device is a safe and effective way to prevent future strokes in people with a PFO.
What could go wrong
This is an observational study, not a randomized trial, so it cannot prove the device is better than other treatments. Results may not apply outside Japan.

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 300 people

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

Started

Oct 2022

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 who have had a cryptogenic stroke (including transient ischemic attack with positive head imaging findings) with possible involvement of patent foramen ovale (PFO) due to a presumed paradoxical embolism.

Ages

18 to 70 years

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: * Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings) * Diagnosed with a PFO * Note: Additional Inclusion Criteria may apply Exclusion Criteria: * N/A

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Conditions

The condition(s) this trial relates to.

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.

Cryptogenic stroke Pfo - patent foramen ovale Stroke TIA

Contacts and locations

Locations

  • Okayama University Hospital

    Okayama, 700-8558, Japan

More trials for these conditions

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