A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
Status: Recruiting
Location: See all (7) 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
NOT_YET_RECRUITING
Curitiba
Universidade Federal do Ceará
NOT_YET_RECRUITING
Fortaleza
Santa Casa de Misericórdia de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
HCOR - Associação Beneficente Síria
NOT_YET_RECRUITING
São Paulo
Hospital Beneficência Portuguesa
NOT_YET_RECRUITING
São Paulo
Greece
Onassis Cardiac Surgery Center
RECRUITING
Kallithea
Italy
IRCCS Policlinico San Donato
RECRUITING
Milan
Contact Information
Primary
Rae Gong, PM
gongrui@lifetechmed.com
(86-755)-86026250-6957
Backup
KaDirr Shemsi, APM
KaDirr@lifetechmed.com
+86-176-2130-9203
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2027-12
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.