To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
Age: 18 to 65 years old, regardless of gender
Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state)
Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine
The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination
Patients have definite causes of stroke unrelated to the PFO
RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt
Atrial fibrillation or atrial flutter
Mitral and aortic stenosis or severe regurgitation
Parallel
SnowyTM PFO closure system
DevicePercutaneously occlusion of PFO with SnowyTM PFO closure system
Cardi-o-fix PFO occluder
DevicePercutaneously occlusion of PFO with Cardi-o-fix PFO occluder
The success rate of PFO effective occlusion
The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I
Number of Participants with Device success
The successful implantation of occluder is defined as the successful delivery and release of occluder during operation, the position of occluder is appropriate and the morphological structure is normal
Number of Participants with Procedural success
The occluder is successfully implanted and there are no severe adverse events (SAE) during routine hospitalization. SAE include but are not limited to death, systemic embolism, occluder embolism/displacement, occluder thrombosis, heart injury and perforation, pericardial tamponade / pericardial effusion (pericardial effusion leads to hemodynamic damage or requires pericardiocentesis; prolonged hospitalization for more than 48 hours; hospitalization is required), infective endocarditis, atrial fibrillation, severe vascular access complications
Complete closure rate
No RLS is confirmed by imaging examination after occluder implantation
Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline)
The scores range from 36 to 78 (higher scores mean a worse outcome).
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