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

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Feb 25, 2025

Keywords

ClinConnect Summary

The Cera™ ASD Occluder Post-Market Clinical Follow-Up Study is designed to gather important information about the Lifetech Cera™ ASD Occluder, a device used to treat a specific heart condition called secundum Atrial Septal Defect (ASD). This study aims to confirm how safe and effective the device is in the long run, as well as to identify any side effects that may not have been known before. The study is currently recruiting participants of all ages who have had this device implanted between January 1, 2020, and December 31, 2023.

To be eligible for the study, patients must have a confirmed diagnosis of ASD and must have had the device implanted as per the instructions. They also need to agree to let researchers collect and use their health information. However, some patients may not qualify if they have certain complex heart conditions, recent infections, bleeding disorders, or other specific health issues. Participants will have the opportunity to contribute to important research that helps improve the care and management of patients with ASD.

Gender

ALL

Eligibility criteria

• 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.