Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
ConditionAtrial Septal Defect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov