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The objective of this post-market study is to:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Procedural success |
| 6 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Successful closure of the defects | With no, trivial or small residual shunt confirmed by Doppler echocardiography | at procedure, discharge(up to 2 days)and 12 months post-implantation |
| Incidence of new onset arrhythmia requiring medical treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD), who needs endovascular aortic repair.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KaDirr Shemsi | Contact | +86-176-2130-9203 | kadirr@lifetechmed.com | |
| Jiaxuan Fu | Contact | 86+13973207184 | fujiaxuan@lifetechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G.V.M.Carint Hospital | Not yet recruiting | Myszków | Poland | |||
| Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Include medication, intervention or surgical treatment
| From attempted procedure to 2 years post-implantation |
| Incidence of device or procedure related Adverse Events (AEs) | Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study medical device and whether anticipated or unanticipated. | From attempted procedure to 2 years post-implantation |
| Incidence of device or procedure related Serious Adverse Events (SAEs) | Adverse event that led to any of the following:
| From attempted procedure to 2 years post-implantation |
| Incidence of death | Death | From attempted procedure to 2 years post-implantation |
| Not yet recruiting |
| Oświęcim |
| Poland |
| Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok | Not yet recruiting | Sanok | Poland |
| Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group | Recruiting | Tychy | Poland |
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| Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group | Not yet recruiting | Ustroń | Poland |
| Dr. Tytus Chałubiński County Hospital | Not yet recruiting | Zakopane | Poland |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |