CeraFlex PFO Closure System PMCF Study

Exclusion Criteria17

• Age <18 years or Age >85 years.
• Patient with a history of ongoing Atrial Fibrillation (AF).
• Patient with malignancy or other illness where life expectancy is less than 1 year.
• Patient not covered by a social security scheme.
• Patients who are participating in an investigational drug or device study currently.
• Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion).
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
• Any contraindication mentioned in the corresponding IFU：
• Patients known to have intracardiac thrombi, especially left atrial or left atrial appendage thrombi, demonstrated by echocardiography. Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.
• Anatomy in which the CeraFlexTM PFO device of the required size would interfere with intra-cardiac structure or intra-vascular structure, such as a pulmonary vein, or aorta root.
• Patients whose heart or vein size is too small to allow TEE probing or catheterization.
• Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization.
• Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Patients whose heart does not have enough tissue to secure the device.
• Patients with hypercoagulation disease.
• Any patient for whom the radius of the device is greater than the distance from the patent foramen ovale to the aortic root or superior vena cava.
• No contraindications specified in the SteerEase introducer IFU.