Does Patent Foramen Ovale Size Matter in Men & Women

Status Completed

Clinical Trial Summary

A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott & Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03904277
Study type	Observational
Source	University of Oregon
Contact
Status	Completed
Phase
Start date	October 1, 2018
Completion date	January 25, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06192173` - Patent Foramen Ovale Closure in Migraine
Recruiting	`NCT04610463` - Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism	N/A
Completed	`NCT02882815` - Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder	N/A
Completed	`NCT04604015` - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Not yet recruiting	`NCT04549272` - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Terminated	`NCT01018355` - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI	N/A
Completed	`NCT00831259` - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)	N/A
Not yet recruiting	`NCT05360771` - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System	N/A
Recruiting	`NCT05546320` - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale	Phase 4
Recruiting	`NCT05561660` - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)	Phase 4
Recruiting	`NCT06120270` - CeraFlex PFO Closure System PMCF Study
Terminated	`NCT01773252` - Right to Left Cardiac Shunt Detection	Phase 3
Completed	`NCT01216423` - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale	N/A
Completed	`NCT03377465` - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis	N/A
Active, not recruiting	`NCT04738071` - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting	`NCT06413147` - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting	`NCT06344494` - Cardiac Interventional ICE Imaging Trial	N/A
Withdrawn	`NCT02378623` - Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Does Patent Foramen Ovale Size Matter in Men and Women

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms