NCT06670781 Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
| NCT ID | NCT06670781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 488 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 488 participants in total. It began in 2025-01-30 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated. The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver.
Eligibility 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
Contact & Investigator
Dr. David Messika-Zeitoun, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06670781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670781 currently recruiting?
Yes, NCT06670781 is actively recruiting participants. Contact the research team at dmessika-zeitoun@ottawaheart.ca for enrollment information.
Where is the NCT06670781 trial being conducted?
This trial is being conducted at Ottawa, Canada, Ottawa, Canada.
Who is sponsoring the NCT06670781 clinical trial?
NCT06670781 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Dr. David Messika-Zeitoun, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 488 participants.
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