Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-30 @ 2:13 PM
Study NCT ID:
NCT06849635
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2025-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Organization:
Study Overview
Official Title:
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: