Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the Lifetech CeraFlex™ Closure System, a device used to treat a heart condition called Atrial Septal Defect (ASD). An ASD is a small hole in the wall that separates the heart's two upper chambers, which can cause problems over time. The trial aims to see how well this device works in real-world settings after patients have it implanted, ensuring it is used according to the guidelines provided.

To participate in this study, you need to have a confirmed diagnosis of ASD and must have already had the Lifetech device implanted. It's important that you or your legal representative can sign a consent form for your data to be used in the study. However, if you haven't had a follow-up visit after leaving the hospital, you won't be eligible. If you choose to participate, you can expect regular follow-ups to monitor your health and the performance of the device. This trial is open to patients of all ages and genders, and it aims to gather valuable information that could help improve heart care for others with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
• • 2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.
• Exclusion Criteria:
• • Patients did not conduct any follow up visit after hospital discharge.