Ceraâ„¢ ASD Occluder Post-Market Clinical Follow-Up Study
Poland139 participantsStarted 2025-01-03
Plain-language 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 Ceraâ„¢ ASD Occluder
* identify previously unknown side-effects
Who can participate
SexALL
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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.