RecruitingNCT05887700

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

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

145 participants

Start Date

Jul 9, 2024

Study Type

OBSERVATIONAL

Conditions

Atrial Septal Defect

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CeraFlex™ Atrial Septal Defect (ASD) Closure System for people with atrial septal defect. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECeraFlex™ Atrial Septal Defect (ASD) Closure System

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.