← Back to Clinical Trials
Recruiting NCT05887700
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Trial Parameters
Condition Atrial Septal Defect
Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 145
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2024-07-09
Completion 2027-12
Interventions
CeraFlex™ Atrial Septal Defect (ASD) Closure System
Brief 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 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.