Cera™ ASD Occluder Post-Market Clinical 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
| Condition(s) | Atrial Septal Defect |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 |
| Who can participate | 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 f |
| Sex | All |
| Lead sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
| Locations | Myszków, Poland; Oświęcim, Poland; Sanok, Poland; Tychy, Poland; Ustroń, Poland; Zakopane, Poland |
| Start date | 2025-01-03 |
| NCT ID | NCT06849635 |
| Official listing | https://clinicaltrials.gov/study/NCT06849635 |