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Search / Trial NCT06670781

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

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Oct 31, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Bubble Study Stroke Echocardiography Patent Foramen Ovale

ClinConnect Summary

This clinical trial is studying two different methods of performing a technique called the Valsalva maneuver to check for a condition known as patent foramen ovale (PFO) in patients who have had a stroke with no clear cause. The trial wants to find out if a new method called the Goal-Directed Valsalva Maneuver, which uses a device to help guide the patient, is better at detecting PFO than the traditional Self-Directed Valsalva Maneuver, where patients are simply asked to "bear down" on their own. This is important because detecting PFO can help prevent future strokes, especially in younger patients who may be at risk.

To be eligible for this trial, participants need to be between the ages of 65 and 74 and have been referred for a specific type of heart ultrasound called transthoracic echocardiography (TTE) with a bubble study. They should be able to provide informed consent and perform the Valsalva maneuver. Participants will undergo both types of maneuvers during their heart ultrasound to see which method works better in finding PFO. The trial is currently recruiting participants, and it aims to improve how strokes are diagnosed and treated in the future.

Gender

ALL

Eligibility criteria

  • 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

About Ottawa Heart Institute Research Corporation

The Ottawa Heart Institute Research Corporation is a leading clinical research organization dedicated to advancing cardiovascular medicine through innovative research and clinical trials. Affiliated with the renowned University of Ottawa Heart Institute, the corporation focuses on conducting high-quality, ethically-driven studies that aim to improve patient outcomes and enhance understanding of heart-related diseases. With a commitment to collaboration and excellence, the organization engages multidisciplinary teams of researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective therapies and interventions for cardiovascular health.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Dr. David Messika-Zeitoun, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported