A Multicenter, Prospective, Single-arm, Observational Study
Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
SUMMARY
The objective of this PMCF study is to: * confirm the safety and performance of the AcuMarkTM Sizing Balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
• The anatomy of ASD is suitable for percutaneous closure;
• Patients are scheduled to perform ASD closure;
• Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
Locations
Other Locations
Turkey
Ankara (Bilkent) City Hospital
RECRUITING
Ankara
Gazi Yasargil Woman and Child Hospital
RECRUITING
Diyarbakır
Gaziantep University Hospital
NOT_YET_RECRUITING
Gaziantep
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
NOT_YET_RECRUITING
Istanbul
Tepecik Training and Research Hospital
RECRUITING
Izmir
Contact Information
Primary
Shen Yuanyuan
shenyuanyuan@lifetechmed.com
86+18504356312
Backup
Fu Jiaxuan
fujiaxuan@lifetechmed.com
86 13973207184
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.