Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing two methods for assessing patent foramen ovale in stroke patients

Official title: Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale

Run by Ottawa Heart Institute Research Corporation · NCT06670781 · Data updated 2026-11-12

This study is testing if a guided breathing technique works better than a self-directed one for checking a heart condition in stroke patients to help improve diagnosis and reduce the chance of future strokes.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment488 (estimated)
SponsorOttawa Heart Institute Research Corporation
Academic / other
Locations2 sites (Ottawa, Ontario and 1 other locations)
StatusRecruiting
StartedJanuary 30, 2025
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedApril 30, 2026
Trial IDNCT06670781 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients referred for a clinically indicated transthoracic echocardiography and bubble study due to cryptogenic stroke.

Probably not a fit

Patients who are unable to perform a self-directed Valsalva maneuver or cannot provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a standardized goal-directed Valsalva maneuver compared to a self-directed Valsalva maneuver for assessing patent foramen ovale (PFO) in patients with cryptogenic stroke. The study aims to improve the accuracy of transthoracic echocardiography (TTE) with bubble study, which is crucial for diagnosing PFO, especially in young patients. By refining the maneuver technique, the trial seeks to enhance patient outcomes and reduce the risk of recurrent strokes associated with PFO. Participants will be recruited from those referred for clinically indicated TTE and bubble studies.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of patent foramen ovale, potentially reducing the incidence of recurrent strokes in affected patients.

How similar studies have gone: Other studies have shown success with similar approaches in improving diagnostic techniques for patent foramen ovale, indicating potential for this method.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Ottawa Heart Institute
    Ottawa, Ontario, Canada
    Recruiting
  • University of Ottawa Heart Institute
    Ottawa, Ontario, Canada
    Not yet recruiting

Study contacts

  • Principal investigator: Dr. David Messika-Zeitoun, MD — Ottawa Heart Institute Research Corporation
  • Study coordinator: Dr. David Messika-Zeitoun, MD
  • Email: dmessika-zeitoun@ottawaheart.ca
  • Phone: 6136967337

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.