Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Exclusion Criteria21

• Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%);
• Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6 points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery blood supply area);
• Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
• Acute myocardial infarction or unstable angina within 6 months;
• Left ventricular aneurysm formation or left ventricular wall movement disorder;
• Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;
• Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure;
• Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
• Atrial fibrillation/atrial flutter (chronic or intermittent);
• Pregnant or planning to become pregnant during the trial;
• Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
• Pulmonary hypertension or patent foramen ovale was a special channel;
• Liver and kidney function impairment (ALT or AST > 3 times the upper limit of normal value, serum creatinine (Cr) > 2 times the upper limit of normal value);
• Uncontrolled hypertension (> 180/100 mmHg);
• Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
• Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
• The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;
• Thrombosis exists at the location or route of implantation;
• Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
• Patients who could not be followed up during the trial;
• Participate in clinical trials of other drugs or medical devices within three months.