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

NARecruitingINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

January 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

October 31, 2026

Conditions
Stroke
Interventions
DEVICE

Experimental: 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.

DEVICE

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.

Trial Locations (2)

K1Y 4W7

NOT_YET_RECRUITING

University of Ottawa Heart Institute, Ottawa

RECRUITING

University of Ottawa Heart Institute, Ottawa

All Listed Sponsors
lead

Ottawa Heart Institute Research Corporation

OTHER