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

Last updated: March 24, 2025
Sponsor: Ottawa Heart Institute Research Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Control - standard of care: Self-Directed Valsalva maneuver

Experimental: Intervention arm: Goal-Directed Valsalva maneuver

Clinical Study ID

NCT06670781
OHSN CRRF ID - 6016
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients referred for a clinically indicated TTE and bubble study

Exclusion

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

Study Design

Total Participants: 488
Treatment Group(s): 2
Primary Treatment: Control - standard of care: Self-Directed Valsalva maneuver
Phase:
Study Start date:
January 30, 2025
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

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