StrokeNCT06670781
Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
A study testing Experimental: Intervention arm: Goal-Directed Valsalva maneuver in people with Stroke, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental: Intervention arm: Goal-Directed Valsalva maneuver
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 488 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Jan 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for a clinically indicated TTE and bubble study
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Dr. David Messika-Zeitoun, MD, 613-696-7337, dmessika-zeitoun@ottawaheart.ca
Dr. David Messika-Zeitoun, MD
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Donna Justus, 613 6967337, djustus@ottawaheart.ca
About this study
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
- Being tested
- Experimental: Intervention arm: Goal-Directed Valsalva maneuver, Control - standard of care: Self-Directed Valsalva maneuver
- Keywords
- Bubble study, Stroke, Echocardiography, patent foramen ovale
- Medical subject headings
- Stroke, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention arm: Goal-Directed Valsalva maneuverDevice
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 maneuverDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control - standard of care: Self-Directed Valsalva maneuver | Sham comparator | 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. Receives: 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 | 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. Receives: Device: Experimental: Intervention arm: Goal-Directed Valsalva maneuver; Device: Control - standard of care: Self-Directed Valsalva maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver.
Measured: From enrollment to the end of echocardiogram (40 minutes from enrollment).
Secondary outcomes (2)
Rate of large shunt positive bubble study.
Measured: From enrollment to the end of echocardiogram (40 minutes from enrollment).
Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver in women and in men.
Measured: From enrollment to the end of echocardiogram (40 minutes from enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start30 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A blinded comparative crossover diagnostic accuracy study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. David Messika-Zeitoun, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670781
- Sponsor's protocol ID
- OHSN CRRF ID - 6016
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernard S, Churchill TW, Namasivayam M, Bertrand PB. Agitated Saline Contrast Echocardiography in the Identification of Intra- and Extracardiac Shunts: Connecting the Dots. J Am Soc Echocardiogr. 2020 Oct 23:S0894-7317(20)30615-5. doi: 10.1016/j.echo.2020.09.013. Online ahead of print.
PubMed 34756394Zhao E, Du Y, Xie H, Zhang Y. Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale. Biomed Res Int. 2019 May 9;2019:9828539. doi: 10.1155/2019/9828539. eCollection 2019.
PubMed 31211145Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915.
PubMed 28902593Mojadidi MK, Winoker JS, Roberts SC, Msaouel P, Zaman MO, Gevorgyan R, Tobis JM. Accuracy of conventional transthoracic echocardiography for the diagnosis of intracardiac right-to-left shunt: a meta-analysis of prospective studies. Echocardiography. 2014 Oct;31(9):1036-48. doi: 10.1111/echo.12583. Epub 2014 Apr 2.
PubMed 24689727Saric M, Armour AC, Arnaout MS, Chaudhry FA, Grimm RA, Kronzon I, Landeck BF, Maganti K, Michelena HI, Tolstrup K. Guidelines for the Use of Echocardiography in the Evaluation of a Cardiac Source of Embolism. J Am Soc Echocardiogr. 2016 Jan;29(1):1-42. doi: 10.1016/j.echo.2015.09.011.
PubMed 26765302Cohen A, Donal E, Delgado V, Pepi M, Tsang T, Gerber B, Soulat-Dufour L, Habib G, Lancellotti P, Evangelista A, Cujec B, Fine N, Andrade MJ, Sprynger M, Dweck M, Edvardsen T, Popescu BA; Reviewers: This document was reviewed by members of the 2018-2020 EACVI Scientific Documents Committee; chair of the 2018-2020 EACVI Scientific Documents Committee. EACVI recommendations on cardiovascular imaging for the detection of embolic sources: endorsed by the Canadian Society of Echocardiography. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):e24-e57. doi: 10.1093/ehjci/jeab008.
PubMed 33709114Yaghi S, Bernstein RA, Passman R, Okin PM, Furie KL. Cryptogenic Stroke: Research and Practice. Circ Res. 2017 Feb 3;120(3):527-540. doi: 10.1161/CIRCRESAHA.116.308447.
PubMed 28154102Mojadidi MK, Zaman MO, Elgendy IY, Mahmoud AN, Patel NK, Agarwal N, Tobis JM, Meier B. Cryptogenic Stroke and Patent Foramen Ovale. J Am Coll Cardiol. 2018 Mar 6;71(9):1035-1043. doi: 10.1016/j.jacc.2017.12.059.
PubMed 29495983
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT06670781
- Acronym / sponsor ID
- OHSN CRRF ID - 6016
- Conditions
- Stroke
- Keywords
- Bubble study, Stroke, Echocardiography, patent foramen ovale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A blinded comparative crossover diagnostic accuracy study
| Arm | Type | Receives |
|---|---|---|
| Control - standard of care: Self-Directed Valsalva maneuver | Sham comparator | Device: Experimental: Intervention arm: Goal-Directed Valsalva maneuver, Device: Control - standard of care: Self-Directed Valsalva maneuverThe 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. |
| Intervention arm: Goal-Directed Valsalva maneuver | Active comparator | Device: Experimental: Intervention arm: Goal-Directed Valsalva maneuver, Device: Control - standard of care: Self-Directed Valsalva maneuverFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred for a clinically indicated TTE and bubble study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention arm: Goal-Directed Valsalva maneuverFor 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, Intervention arm: Goal-Directed Valsalva maneuver |
| Control - standard of care: Self-Directed Valsalva maneuverThe 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. | Device | Control - standard of care: Self-Directed Valsalva maneuver, Intervention arm: Goal-Directed Valsalva maneuver |
Primary outcome
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).
2 secondary outcomes
Rate of large shunt positive bubble study.
Time frame: From enrollment to the end of echocardiogram (40 minutes from enrollment).
Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver in women and in men.
Time frame: From enrollment to the end of echocardiogram (40 minutes from enrollment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 34756394Bernard S, Churchill TW, Namasivayam M, Bertrand PB. Agitated Saline Contrast Echocardiography in the Identification of Intra- and Extracardiac Shunts: Connecting the Dots. J Am Soc Echocardiogr. 2020 Oct 23:S0894-7317(20)30615-5. doi: 10.1016/j.echo.2020.09.013. Online ahead of print.
- Background: PubMed 31211145Zhao E, Du Y, Xie H, Zhang Y. Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale. Biomed Res Int. 2019 May 9;2019:9828539. doi: 10.1155/2019/9828539. eCollection 2019.
- Background: PubMed 28902593Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915.
- Background: PubMed 24689727Mojadidi MK, Winoker JS, Roberts SC, Msaouel P, Zaman MO, Gevorgyan R, Tobis JM. Accuracy of conventional transthoracic echocardiography for the diagnosis of intracardiac right-to-left shunt: a meta-analysis of prospective studies. Echocardiography. 2014 Oct;31(9):1036-48. doi: 10.1111/echo.12583. Epub 2014 Apr 2.
- Background: PubMed 26765302Saric M, Armour AC, Arnaout MS, Chaudhry FA, Grimm RA, Kronzon I, Landeck BF, Maganti K, Michelena HI, Tolstrup K. Guidelines for the Use of Echocardiography in the Evaluation of a Cardiac Source of Embolism. J Am Soc Echocardiogr. 2016 Jan;29(1):1-42. doi: 10.1016/j.echo.2015.09.011.
- Background: PubMed 33709114Cohen A, Donal E, Delgado V, Pepi M, Tsang T, Gerber B, Soulat-Dufour L, Habib G, Lancellotti P, Evangelista A, Cujec B, Fine N, Andrade MJ, Sprynger M, Dweck M, Edvardsen T, Popescu BA; Reviewers: This document was reviewed by members of the 2018-2020 EACVI Scientific Documents Committee; chair of the 2018-2020 EACVI Scientific Documents Committee. EACVI recommendations on cardiovascular imaging for the detection of embolic sources: endorsed by the Canadian Society of Echocardiography. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):e24-e57. doi: 10.1093/ehjci/jeab008.
- Background: PubMed 28154102Yaghi S, Bernstein RA, Passman R, Okin PM, Furie KL. Cryptogenic Stroke: Research and Practice. Circ Res. 2017 Feb 3;120(3):527-540. doi: 10.1161/CIRCRESAHA.116.308447.
- Background: PubMed 29495983Mojadidi MK, Zaman MO, Elgendy IY, Mahmoud AN, Patel NK, Agarwal N, Tobis JM, Meier B. Cryptogenic Stroke and Patent Foramen Ovale. J Am Coll Cardiol. 2018 Mar 6;71(9):1035-1043. doi: 10.1016/j.jacc.2017.12.059.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. David Messika-Zeitoun, MD principal investigator
Ottawa Heart Institute Research Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention arm: Goal-Directed Valsalva maneuver in people with Stroke, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. David Messika-Zeitoun, MD (6136967337, dmessika-zeitoun@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06670781, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.