To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
Aged between 18 and 65 years.
Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).
Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).
An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.
Large territory cerebral infarction within 4 weeks prior to the planned procedure.
Atherosclerotic stenosis (>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.
Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.