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A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 9, 2024
Primary Completion Date
December 1, 2027
Completion Date
December 1, 2027
Last Updated
January 8, 2025
145
ESTIMATED participants
CeraFlex™ Atrial Septal Defect (ASD) Closure System
DEVICE
Lead Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06849635