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New breathing technique could uncover hidden stroke cause

NCT ID NCT06670781

Diagnosis Sponsor: Ottawa Heart Institute Research Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of performing the Valsalva maneuver during a heart ultrasound to detect a patent foramen ovale (PFO), a small hole in the heart that can cause strokes. About 488 stroke patients will be asked to do both a standard self-directed maneuver and a goal-directed maneuver using a manometer to measure their effort. The goal is to see if the goal-directed method finds more PFOs, which could lead to better treatment and fewer repeat strokes.

What this could mean

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

Active substance
Goal-directed Valsalva maneuver using a manometer device
What this could lead to
If successful, this could improve detection of PFO in stroke patients, leading to more accurate diagnosis and treatment to prevent recurrent strokes.
What could go wrong
This is a diagnostic method comparison, not a treatment trial. Even if it improves detection, it may not change patient outcomes. The study is still recruiting and results are not yet available.

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 488 people

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

Started

Jan 2025

Expected to finish

Oct 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.

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: * Patients referred for a clinically indicated TTE and bubble study Exclusion Criteria: * Inability to provide informed consent * Inability to insert an IV line * Inability to perform a Self-Directed Valsalva maneuver * Patient wishing to keep his mask on

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Conditions

The condition(s) this trial relates to.

patent foramen ovale stroke disorder

As listed by the trial registrant

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

Stroke

How to take part

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

  1. The places running it

    2 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

  • University of Ottawa Heart Institute

    NOT_YET_RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

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