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

Summary

The objective of this post-market study is to: * collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder * identify previously unknown side-effects

Eligibility

Inclusion Criteria:

* Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
* Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
* Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.

Exclusion Criteria:

* Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
* Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
* 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.
* Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
* Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
* Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
* Patients did not conduct any follow up visit after hospital discharge.

Conditions2

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