Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CeraFlex™ Atrial Septal Defect (ASD) Closure System.
- Who it may be relevant to
- Registry conditions: Atrial Septal Defect. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
Overview
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.
Detailed description
The study intends to collect data from patients who have implanted with the device in 2019 or later.
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.
Primary outcome measures
- Procedural success [Time frame: 6 months post-implantation]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
Patients did not conduct any follow up visit after hospital discharge.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 4 centers
- Hospital Pequeno Príncipe — Curitiba
- Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
- HCOR - Associação Beneficente Síria — São Paulo
- Hospital Beneficência Portuguesa — São Paulo
Greece · 1 center
- Onassis Cardiac Surgery Center — Kallithea
Identifiers
NCT: NCT05887700 · LT-TS-271-2023-01