Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
Lifetech Scientific (Shenzhen) Co., Ltd.
145 participants
Jul 9, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
- Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.
Exclusion Criteria1
- Patients did not conduct any follow up visit after hospital discharge.
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Interventions
The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05887700