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Heart hole or stroke trigger? global registry tracks who gets closure and what happens next

NCT ID NCT04738071

Knowledge-focused Sponsor: Luciano A. Sposato 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are running an international registry to follow adults who had an ischemic stroke or transient ischemic attack and also have a patent foramen ovale, a small opening between the upper chambers of the heart. The registry collects real-world information on how these patients are treated, including whether they undergo a procedure to close the opening, and tracks outcomes such as recurrent stroke and new atrial fibrillation. By gathering data across many countries and healthcare systems, the study aims to show how findings from controlled trials translate into everyday practice.

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, a device procedure that seals a hole in the heart
What this could lead to
If the registry clarifies how PFO closure performs outside controlled trials, it could sharpen guidance on which stroke patients benefit from the procedure.
What could go wrong
This is an observational registry, so it can show patterns but cannot prove cause and effect. Results may be confounded by differences in how patients are selected for closure across regions.

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

3,730 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Nov 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.

Who is studied

The IMPROVE registry aims to include patients from Asia, Europe, Oceania, North America and Latin America. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists, since a confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment.

Ages

18 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 (all of the following criteria should be fulfilled) * Age ≥18 years * Ischemic stroke or TIA within 5 years and 1 year before inclusion in the registry. Patients with cerebrovascular events occurred within one year before the inclusion in the registry should be part of the prospective cohort. * Ischemic stroke is defined as: * focal neurological deficit of central origin lasting ≥24 hours -except for death within 24hrs- with or without imaging confirmation of cerebral infarction; or * focal neurological deficit of central origin lasting \<24 hours with corresponding imaging evidence of cerebral infarction; or * focal neurological deficit of central origin lasting \<24 hours in patients receiving IV thrombolysis or endovascular thrombectomy with or without imaging confirmation of cerebral infarction; or * non-focal encephalopathy lasting more than 24 hours -except for death within 24hrs- with imaging evidence of cerebral infarction; or * acute and permanent retinal ischemia of arterial origin. * TIA is defined as: * focal neurological deficit of central origin lasting \<24 hours without corresponding imaging evidence of cerebral infarction in patients not receiving IV thrombolysis or endovascular thrombectomy. * Confirmed patent foramen ovale. EXCLUSION CRITERIA: Exclusion Criteria * Age \<18 years * Venous stroke * Stroke mimics * Patients with incomplete data at 12 months after the index ischemic stroke or TIA.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter 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 Atrial flutter Patent foramen ovale Stroke

Contacts and locations

Locations

  • Heart & Brain Lab, Western University

    London, Ontario, N6A 5A5, Canada

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