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

Recruiting now

Conditions studied: Atrial Septal Defect

In brief

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.

Key facts

Study ID

NCT05887700

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

145

Starts

2024-07-09

Expected to finish

2027-06-30

Last updated by the study team

2026-05-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients did not conduct any follow up visit after hospital discharge.

Where it is running

• Hospital Pequeno Príncipe — Curitiba, Brazil (enrolling)
• Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil (enrolling)
• HCOR - Associação Beneficente Síria — São Paulo, Brazil (enrolling)
• Hospital Beneficência Portuguesa — São Paulo, Brazil (enrolling)
• Onassis Cardiac Surgery Center — Kallithea, Greece (enrolling)

Full record on ClinicalTrials.gov

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