Cera™ ASD Occluder Post-Market Clinical Follow-Up Study

Successful closure of the defects

With no, trivial or small residual shunt confirmed by Doppler echocardiography

Time frame: at procedure, discharge（up to 2 days）and 12 months post-implantation

Incidence of new onset arrhythmia requiring medical treatment

Include medication, intervention or surgical treatment

Time frame: From attempted procedure to 2 years post-implantation

Incidence of device or procedure related Adverse Events (AEs)

Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study medical device and whether anticipated or unanticipated.

Time frame: From attempted procedure to 2 years post-implantation

Incidence of device or procedure related Serious Adverse Events (SAEs)

Adverse event that led to any of the following: 1. death, 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure or a body function including chronic diseases, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment