U.S., May 22 -- ClinicalTrials.gov registry received information related to the study (NCT06983613) titled 'New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure' on March 07.
Brief Summary: Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS. When specific anatomic criteria are met, transcatheter PFO occlusion is regarded as the gold standard for secondary stroke prevention.
However, previous studies have shown that percutaneous PFO closure may increase the risk of new-onset atrial fibrillation and atrial flutter (AF), arrhythmias that elevate the risk of embolic stroke. This raises concerns about performin...