Valsalva Maneuver Techniques for Patent Foramen Ovale Detection

Overseen By Roja Gauda, Masters of Applied Science

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Informed consent, IV line, Valsalva, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

488 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Goal-Directed Valsalva Maneuver, Self-Directed Valsalva Maneuver for Patent Foramen Ovale Detection?

The Valsalva maneuver is considered a sensitive test for detecting patent foramen ovale (PFO), especially when performed adequately, as it helps identify a right-to-left shunt, which is a key indicator of PFO. ^{1 2 3 4 5}

Is the Valsalva maneuver safe for detecting patent foramen ovale?

The standardized Valsalva maneuver is considered safe and useful for detecting a patent foramen ovale, which is a small opening in the heart that can lead to certain types of strokes. ^{1 4 5 6 7}

How does the Goal-Directed Valsalva Maneuver treatment differ from other treatments for patent foramen ovale detection?

The Goal-Directed Valsalva Maneuver is unique because it standardizes the pressure applied during the maneuver, potentially reducing variability between individuals and improving the accuracy of detecting a patent foramen ovale (a small hole in the heart). This approach contrasts with traditional methods that rely on patients' ability to perform the maneuver, which can be inconsistent. ^{1 2 4 5 8}

What is the purpose of this trial?

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.

Research Team

Dr. David Messika-Zeitoun, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

This trial is for individuals who have had a stroke with no clear cause identified, suggesting the possibility of a heart condition called Patent Foramen Ovale (PFO), particularly in younger patients. Specific eligibility criteria are not provided.

Inclusion Criteria

Patients referred for a clinically indicated TTE and bubble study

Exclusion Criteria

I am unable to understand or sign the consent form.

I cannot have an IV line inserted.

I prefer to wear my mask during the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a Self-Directed or Goal-Directed Valsalva maneuver for the assessment of patent foramen ovale

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the Valsalva maneuver

4 weeks

Treatment Details

Interventions

• Goal-Directed Valsalva Maneuver
• Self-Directed Valsalva Maneuver

Trial Overview The study aims to compare two methods of performing the Valsalva maneuver—a technique used during echocardiography to detect PFO. One group will use a Goal-Directed method with a manometer for consistency, while the control group will perform it as usually instructed without specific tools.

Participant Groups

Group I: Intervention arm: Goal-Directed Valsalva maneuver Active Control 2 Interventions

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.

Group II: Control - standard of care: Self-Directed Valsalva maneuver Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Estimation of patent foramen ovale size using transcranial Doppler ultrasound in patients with ischemic stroke. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

[Presence of patent foramen ovale in different heart diseases: incidence in 211 consecutive patients studied by transesophageal echocardiography]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Importance of an adequately performed Valsalva maneuver for detecting a right-to-left shunt indicating foramen ovale reopening. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

End-inspiratory occlusion maneuver during transesophageal echocardiography for patent foramen ovale detection in intensive care unit patients. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Inferior Vena Cava Compression as a Novel Maneuver to Detect Patent Foramen Ovale: A Transesophageal Echocardiographic Study. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

Detection of right to left shunting through a patent foramen ovale in Japanese patients with ischemic stroke by transesophageal echocardiography using a standardized Valsalva maneuver. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

The cough test is superior to the Valsalva maneuver in the delineation of right-to-left shunting through a patent foramen ovale during contrast transesophageal echocardiography. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Calf muscle pump tensing as a novel maneuver to improve the diagnostic performance of detecting patent foramen ovale during transesophageal echocardiography. [2023]