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Cera™ ASD Occluder Post-Market Clinical Follow-Up Study:A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
The objective of this post-market study is to: * collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder * identify previously unknown side-effects
Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.
Age
All ages
Sex
ALL
Healthy Volunteers
No
G.V.M.Carint Hospital
Myszków, Poland
Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim
Oświęcim, Poland
Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok
Sanok, Poland
Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
Tychy, Poland
Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group
Ustroń, Poland
Dr. Tytus Chałubiński County Hospital
Zakopane, Poland
Start Date
January 3, 2025
Primary Completion Date
December 31, 2025
Completion Date
February 28, 2026
Last Updated
March 6, 2025
139
ESTIMATED participants
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 ConditionsNCT05887700