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

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Stroke

Treatments: Device: Control - standard of care: Self-Directed Valsalva maneuver; Device: Experimental: Intervention arm: Goal-Directed Valsalva maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT06670781

OHSN CRRF ID - 6016

Details and patient eligibility

About

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.

Enrollment: 488 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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488 participants in 2 patient groups

Control - standard of care: Self-Directed Valsalva maneuver

Sham Comparator group

Description:

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.

Treatment:

Device: Experimental: Intervention arm: Goal-Directed Valsalva maneuver

Device: Control - standard of care: Self-Directed Valsalva maneuver

Intervention arm: Goal-Directed Valsalva maneuver

Active Comparator group

Description:

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.

Treatment:

Device: Experimental: Intervention arm: Goal-Directed Valsalva maneuver

Device: Control - standard of care: Self-Directed Valsalva maneuver