Clinical trial NCT06849635: Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
Official title: Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Septal Defect
Keywords: Atrial Septal Defect
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD), who needs endovascular aortic repair.

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

Detailed 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.

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.

Primary outcomes:
measure: Procedural success
timeFrame: 6 months post-implantation
Secondary outcomes:
measure: Successful closure of the defects
timeFrame: at procedure, discharge（up to 2 days）and 12 months post-implantation
measure: Incidence of new onset arrhythmia requiring medical treatment
timeFrame: From attempted procedure to 2 years post-implantation
measure: Incidence of device or procedure related Adverse Events (AEs)
timeFrame: From attempted procedure to 2 years post-implantation
measure: Incidence of device or procedure related Serious Adverse Events (SAEs)
timeFrame: From attempted procedure to 2 years post-implantation
measure: Incidence of death
timeFrame: From attempted procedure to 2 years post-implantation
Other outcomes:
Locations:
city: Myszków
country: Poland
facility: G.V.M.Carint Hospital
city: Oświęcim
country: Poland
facility: Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim
city: Sanok
country: Poland
facility: Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok
city: Tychy
country: Poland
facility: Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
city: Ustroń
country: Poland
facility: Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group
city: Zakopane
country: Poland
facility: Dr. Tytus Chałubiński County Hospital
Study officials:
References: