Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
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
- This is an observational study: the protocol does not assign a study treatment.
- 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
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
Overview
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
Detailed description
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.
Primary outcome measures
- Procedural success [Time frame: 6 months post-implantation]
Secondary outcome measures (5)
- Successful closure of the defects [Time frame: at procedure, discharge（up to 2 days）and 12 months post-implantation]
- Incidence of new onset arrhythmia requiring medical treatment [Time frame: From attempted procedure to 2 years post-implantation]
- Incidence of device or procedure related Adverse Events (AEs) [Time frame: From attempted procedure to 2 years post-implantation]
- Incidence of device or procedure related Serious Adverse Events (SAEs) [Time frame: From attempted procedure to 2 years post-implantation]
- Incidence of death [Time frame: From attempted procedure to 2 years post-implantation]
Eligibility criteria
Inclusion criteria
- Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
- Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
- Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.
Exclusion criteria
- Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
- Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
- Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
- Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
- Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
- Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
- 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.
Study design
- Observational model
- Cohort
Study locations
Poland · 6 centers
- G.V.M.Carint Hospital — Myszków
- Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim — Oświęcim
- Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok — Sanok
- Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Polan — Tychy
- Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in U — Ustroń
- Dr. Tytus Chałubiński County Hospital — Zakopane
Identifiers
NCT: NCT06849635 · LT-TS-27-2025-01