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

LifeTech Scientific

Status: Enrolling

Conditions: Atrial Septal Defect

Study type: Observational

Funder types: Industry

Identifiers

NCT06849635

LT-TS-27-2025-01

Details and patient eligibility

About

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

Full description

Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.

Enrollment: 139 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.