Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Eligibility
Participation Requirements
Sex: All
View:
• Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
• Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
• Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.
Locations
Other Locations
Poland
G.V.M.Carint Hospital
NOT_YET_RECRUITING
Myszków
Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim
NOT_YET_RECRUITING
Oświęcim
Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok
NOT_YET_RECRUITING
Sanok
Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
RECRUITING
Tychy
Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group
NOT_YET_RECRUITING
Ustroń
Dr. Tytus Chałubiński County Hospital
NOT_YET_RECRUITING
Zakopane
Contact Information
Primary
KaDirr Shemsi
kadirr@lifetechmed.com
+86-176-2130-9203
Backup
Jiaxuan Fu
fujiaxuan@lifetechmed.com
86+13973207184
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 139
Related Therapeutic Areas
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.