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

RecruitingNAAges 18 Years - anyAllOttawa Heart Institute Research Corporation
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In plain words

What the trial is, and whether it could suit you

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 a

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๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Experimental: Intervention arm: Goal-Directed Valsalva maneuver
  • Control - standard of care: Self-Directed Valsalva maneuver
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Where

2 sites
University of Ottawa Heart Institute
Ottawa, Canada
University of Ottawa Heart Institute
Ottawa, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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