Recruiting

Standardized Goal-Directed vs. Self-Directed

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06670781

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental: Intervention arm: Goal-Directed Valsalva maneuver

Control - standard of care: Self-Directed Valsalva maneuver

Study Details

Brief 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.

Conditions

Stroke

Study ID

NCT06670781

Start date

Jan 30, 2025

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

488 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver. [ Time Frame: From enrollment to the end of echocardiogram (40 minutes from enrollment). ]

Central Contacts and Locations

Central contacts

Dr. David Messika-Zeitoun, MD

6136967337dmessika-zeitoun@ottawaheart.ca

Roja Gauda, Masters of Applied Science

6136967000rgauda@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Bubble study
  • Stroke
  • Echocardiography
  • patent foramen ovale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-04-30.