NCT06849635 Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
| NCT ID | NCT06849635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
| Condition | Atrial Septal Defect |
| Study Type | OBSERVATIONAL |
| Enrollment | 139 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 139 participants in total. It began in 2025-01-03 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06849635 clinical trial?
This trial is open to participants of all sexes, studying Atrial Septal Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06849635 currently recruiting?
Yes, NCT06849635 is actively recruiting participants. Contact the research team at kadirr@lifetechmed.com for enrollment information.
Where is the NCT06849635 trial being conducted?
This trial is being conducted at Myszków, Poland, Oświęcim, Poland, Sanok, Poland, Tychy, Poland and 2 additional locations.
Who is sponsoring the NCT06849635 clinical trial?
NCT06849635 is sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. The trial plans to enroll 139 participants.