A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
• Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.
Locations
Other Locations
Brazil
Hospital Pequeno Príncipe
RECRUITING
Curitiba
Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
HCOR - Associação Beneficente Síria
RECRUITING
São Paulo
Hospital Beneficência Portuguesa
RECRUITING
São Paulo
Greece
Onassis Cardiac Surgery Center
RECRUITING
Kallithea
Contact Information
Primary
Rae Gong
gongrui@lifetechmed.com
(86-755)-86026250-6957
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 145
Treatments
ASD subjects
Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Related Therapeutic Areas
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.