RecruitingNCT06849635

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

Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

139 participants

Start Date

Jan 3, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Septal Defect

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 Criteria3

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 Criteria7

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.

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