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Cera™ ASD Occluder Post-Market Clinical Follow-Up Study

Recruitingn/aAges any - anyAllLifetech Scientific (Shenzhen) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

6 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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