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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients referred for a clinically indicated TTE and bubble study

Locations
Other Locations
Canada
University of Ottawa Heart Institute
NOT_YET_RECRUITING
Ottawa
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
Dr. David Messika-Zeitoun, MD
dmessika-zeitoun@ottawaheart.ca
6136967337
Backup
Roja Gauda, Masters of Applied Science
rgauda@ottawaheart.ca
6136967000
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2026-10
Participants
Target number of participants: 488
Treatments
Sham_comparator: Control - standard of care: Self-Directed Valsalva maneuver
The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium.
Active_comparator: Intervention arm: Goal-Directed Valsalva maneuver
For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly.
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov