Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06670781

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

Led by Ottawa Heart Institute Research Corporation · Updated on 2026-04-30

488

Participants Needed

2

Research Sites

87 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred for a clinically indicated transthoracic echocardiogram (TTE) and bubble study
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Not Yet Recruiting

2

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

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Research Team

D

Dr. David Messika-Zeitoun, MD

CONTACT

R

Roja Gauda, Masters of Applied Science

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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