Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale
NCT07726927
Cardiovascular Abnormalities, Cardiovascular Diseases
View Trial DetailsNCT Number: NCT07742540
Before birth, the foramen ovale is a normal opening in the heart that allows blood to flow from the mother to the baby. After birth, this opening usually closes. However, in up to 38% of the population it does not fully close and is then called a patent foramen ovale (PFO). Having a PFO allows venous (blue) blood to mix with arterial (red) blood in the heart, which can lower blood oxygen levels. The mixing of blood has been suggested to be greater during exercise and with exposure to high-altitude. Also, people with a PFO may be a greater risk for severe altitude sickness, specifically involving the collection of fluid in the lungs which makes breathing very difficult - this is called high-altitude pulmonary edema (HAPE).
No study has directly measured the pressure difference across the heart which is required for the mixing of blood during exercise or at high-altitude. The present study will directly measure the pressure difference across the heart, as well as blood flow through the PFO during rest and exercise in simulated high altitude in adults with and without a PFO and a previous history of severe altitude sickness. The study will test the hypothesis that elevations in pulmonary artery pressure during exposure to hypoxia will not elicit a pressure gradient, and thus blood flow, across the PFO neither at rest nor during exercise.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Absolute difference between pulmonary capillary wedge pressure and right atrial pressure
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Oxygen uptake and carbon dioxide production
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Time frame: During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
Contact information is provided by the study sponsor or research team.
Giorgio Manferdelli, Ph.D.
CONTACT
Mary Childers
CONTACT
University of Texas Southwestern Medical Center
Other
The Role of Patent Foramen Ovale on Cardiac Hemodynamics and Exercise Cardiac Reserve in HAPE-susceptible Individuals
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