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

NCT06670781 | Recruiting

• 1 other identifier: OHSN CRRF ID - 6016
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 2

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

Keywords

Bubble study; Stroke; Echocardiography; patent foramen ovale

Outcome Measures

Primary Outcomes (1)

• Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver.

  From enrollment to the end of echocardiogram (40 minutes from enrollment).

Secondary Outcomes (2)

• Rate of large shunt positive bubble study.

  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.

  From enrollment to the end of echocardiogram (40 minutes from enrollment).

Study Arms (2)

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.

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.

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

Interventions

Experimental: Intervention arm: Goal-Directed Valsalva maneuver DEVICE

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; Intervention arm: Goal-Directed Valsalva maneuver

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for a clinically indicated TTE and bubble study

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

NOT YET RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 34756394 BACKGROUND

• Zhao 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.

  PMID: 31211145 BACKGROUND

• Mas 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.

  PMID: 28902593 BACKGROUND

• Mojadidi 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.

  PMID: 24689727 BACKGROUND

• Saric 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.

  PMID: 26765302 BACKGROUND

• Cohen 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.

  PMID: 33709114 BACKGROUND

• Yaghi 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.

  PMID: 28154102 BACKGROUND

• Mojadidi MK, Mahmoud AN, Patel NK, Elgendy IY, Meier B. Cryptogenic Stroke and Patent Foramen Ovale: Ready for Prime Time? J Am Coll Cardiol. 2018 Sep 4;72(10):1183-1185. doi: 10.1016/j.jacc.2018.03.549. No abstract available.

  PMID: 30165998 BACKGROUND

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dr. David Messika-Zeitoun, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. David Messika-Zeitoun, MD

CONTACT

6136967337; dmessika-zeitoun@ottawaheart.ca

Roja Gauda, Masters of Applied Science

CONTACT

6136967000; rgauda@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A blinded comparative crossover diagnostic accuracy study

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 1, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)