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.
The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.
Study Type
OBSERVATIONAL
Enrollment
145
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.
Hospital Pequeno Príncipe
Curitiba, Brazil
NOT_YET_RECRUITINGUniversidade Federal do Ceará
Fortaleza, Brazil
NOT_YET_RECRUITINGSanta Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Procedural success
Procedural success is defined as a composite of: 1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.
Time frame: 6 months post-implantation
Incidence of moderate or large residual shunt
Time frame: At procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of death
Time frame: From attempted procedure to 24 months post-implantation
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HCOR - Associação Beneficente Síria
São Paulo, Brazil
NOT_YET_RECRUITINGHospital Beneficência Portuguesa
São Paulo, Brazil
NOT_YET_RECRUITINGOnassis Cardiac Surgery Center
Kallithea, Greece
RECRUITINGIRCCS Policlinico San Donato
Milan, Italy
RECRUITING