NCT06849635

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

Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 139 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Atrial Septal Defect

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2025-02-27
• Last updated: 2025-03-06

Locations

6 sites across 1 country: Poland