Actively Recruiting
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2024-11-21
100
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients confirmed to have single secundum atrial septal defect by echocardiography
- Anatomy of ASD suitable for percutaneous closure
- Patients scheduled for ASD closure
- Patients or legally authorized representatives willing and able to provide informed consent
You will not qualify if you...
- Any contraindication for ASD closure
- Patients with ostium primum ASD or coronary sinus ASD
- Pregnant or breastfeeding patients
- Patients currently participating in another clinical trial without completed primary endpoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Ankara (Bilkent) City Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
2
Gazi Yasargil Woman and Child Hospital
Diyarbakır, Turkey (Türkiye)
Actively Recruiting
3
Gaziantep University Hospital
Gaziantep, Turkey (Türkiye)
Not Yet Recruiting
4
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
5
Tepecik Training and Research Hospital
Izmir, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Shen Yuanyuan
CONTACT
F
Fu Jiaxuan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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