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 in 2019 or later.
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
RECRUITINGSanta Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
RECRUITINGHCOR - Associação Beneficente Síria
São Paulo, Brazil
RECRUITINGProcedural 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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Hospital Beneficência Portuguesa
São Paulo, Brazil
RECRUITINGOnassis Cardiac Surgery Center
Kallithea, Greece
RECRUITING