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

Recruiting now

Conditions studied: Atrial Septal Defect

In brief

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

Key facts

Study ID

NCT06849635

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

139

Starts

2025-01-03

Expected to finish

2026-02-28

Last updated by the study team

2025-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group — Tychy, Poland (enrolling)
• 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 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group — Ustroń, Poland
• Dr. Tytus Chałubiński County Hospital — Zakopane, Poland

Full record on ClinicalTrials.gov

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