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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores improved methods for detecting a heart condition called patent foramen ovale (PFO), which can be linked to unexplained strokes. Researchers compare two techniques for performing the Valsalva maneuver, a breathing exercise used during heart tests. The goal is to determine if a new, goal-directed method using a device is superior to the standard self-directed method. Eligible participants are those already scheduled for a specific heart test that includes a bubble study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance heart condition detection methods.

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 prior data suggests that these Valsalva maneuver techniques are safe for detecting PFO?

Research has shown that the Goal-Directed Valsalva Maneuver is generally safe for detecting a patent foramen ovale (PFO), a heart defect that can cause strokes. Studies on similar methods have found them to be well-tolerated by patients. This approach involves blowing into a device to reach a certain pressure, enhancing test accuracy.

No evidence indicates major side effects from this maneuver. Since this study is not part of the usual drug trial phases, the technique is neither a new medication nor an invasive procedure. Instead, it improves a common test, reducing safety concerns. Participants can thus expect a safe experience with the Goal-Directed Valsalva Maneuver during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to detect Patent Foramen Ovale (PFO) using the Goal-Directed Valsalva Maneuver. Unlike the standard self-directed method, which relies on patients performing the maneuver without specific feedback, this technique involves blowing into a device to maintain a specific pressure, providing more control and potentially more accurate results. This added precision could improve PFO detection, helping to better diagnose and treat related cardiovascular conditions.

What evidence suggests that the Goal-Directed Valsalva Maneuver is effective for detecting PFO?

This trial will compare the Goal-Directed Valsalva Maneuver with the Self-Directed Valsalva Maneuver for detecting a patent foramen ovale (PFO). Research shows that the Goal-Directed Valsalva Maneuver might be more effective at identifying a PFO than the self-directed approach. A PFO is a small opening in the heart that can lead to strokes if not detected and treated. Studies have found that using a manometer, a tool that measures pressure, to guide the Valsalva Maneuver enhances its consistency and effectiveness in detecting PFO. Although the exact improvement in PFO detection with this method is still under investigation, earlier research in similar contexts has shown promising results. This method aims to improve detection reliability, potentially aiding in better stroke risk management. ^{1 3 4 6 7}

Who Is on the Research Team?

Dr. David Messika-Zeitoun, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trialx.com trialx.com/clinical-trials/listings/315488/standardized-goal-directed-vs-self-directed-valsalva-maneuver-for-the-assessment-of-patent-foramen-ovale/

Standardized Goal-Directed vs. Self-Directed Valsalva ... 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 ...

2. mdpi.com mdpi.com/2308-3425/12/10/400

Evaluating Incidence and Causes of False Positive Patent ... PFO was confirmed in 326 patients (94.2%), whereas 20 patients (5.8%, 95% CI 3.6–8.9%) were adjudicated as false positives during subsequent cardiac ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.040546

Patent Foramen Ovale Management for Secondary Stroke ... Data from clinical trials suggest that up to 6.6% of patients with stroke undergoing PFO closure develop AF in the ensuing weeks, with 83% of AF ...

4. academic.oup.com academic.oup.com/ehjimp/article/3/1/qyaf080/8161142

Impact of party balloon inflation manoeuvre during saline ... This study aimed to demonstrate the superiority of the PBIM over standard provocative methods (conventional or abdominal compression VM) during ASC-TTE.

5. jacc.org jacc.org/doi/10.1016/j.jcin.2018.03.008

Incidence and Outcomes of Positive Bubble Contrast Study ... The study met its primary endpoint, demonstrating that PFO closure plus antiplatelet therapy reduced the risk for stroke recurrence compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12565186/

PMC - PubMed Central PFO was confirmed in 326 patients (94.2%), whereas 20 patients (5.8%, 95% CI 3.6–8.9%) were adjudicated as false positives during subsequent cardiac ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2018.10.061

Long-Term Follow-Up After Closure of Patent Foramen ... The results of this study showing the low stroke rate >10 years post-PFO closure support the long-term efficacy and safety of this treatment for ...