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RECRUITING
NCT05887700

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

Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

145

Start Date

2024-07-09

Completion Date

2027-12

Last Updated

2025-01-08

Healthy Volunteers

No

Interventions

DEVICE

CeraFlex™ 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.

Locations (7)

Hospital Pequeno Príncipe

Curitiba, Brazil

Universidade Federal do Ceará

Fortaleza, Brazil

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

HCOR - Associação Beneficente Síria

São Paulo, Brazil

Hospital Beneficência Portuguesa

São Paulo, Brazil

Onassis Cardiac Surgery Center

Kallithea, Greece

IRCCS Policlinico San Donato

Milan, Italy