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.
Parallel
Active Comparator
DevicePercutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Experimental
DeviceTranscatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder
Success rate of effective occlusion
Effective occlusion was defined as: 12 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.
Success rate of effective occlusion
Effective occlusion was defined as: 6 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.
Device Success Rate
Successful intraoperative deployment of the occluder, with immediate post-procedure echocardiography confirming appropriate device morphology and position, absence of new pericardial effusion or valvular regurgitation, and successful retrieval of the delivery system
Procedural success Rate
Successful device implantation without any procedure- or device-related complications prior to discharge. Complications include atrial fibrillation, other serious arrhythmic events, thrombosis, cerebral embolism, pericardial effusion, cardiac tamponade, device embolization, or displacement
Recurrence or incidence of cryptogenic stroke or TIA
Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.
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