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

RECRUITINGSponsored by Lifetech Scientific (Shenzhen) Co., Ltd.
Actively Recruiting
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
Started2024-07-09
Est. completion2027-12
Eligibility
Healthy vol.Accepted

Summary

The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.

Eligibility

Healthy volunteers accepted
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.

Conditions2

Atrial Septal DefectHeart Disease

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