Actively Recruiting
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-03-06
139
Participants Needed
6
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
- Patients implanted with the Lifetech Cera™ ASD Occluder device from 01 Jan 2020 to 31 Dec 2023 as per instructions for use.
- Patients or their legally authorized representatives willing to allow collection and processing of their data or sign informed consent.
You will not qualify if you...
- Patients with extensive congenital cardiac anomalies that require surgical repair.
- Patients with sepsis within one month prior to implantation or any untreated systemic infection.
- Patients known to have bleeding disorders, untreated ulcers, or contraindications to aspirin therapy unless alternative anti-platelet therapy is possible for 6 months.
- Patients with intra-cardiac thrombi, especially in the left atrium or left atrial appendage.
- Patients too small to tolerate transesophageal echocardiography probe or catheter, or with active infections making cardiac catheterization unsuitable.
- Patients whose defect margins are less than 5mm from coronary sinus, AV valves, or right upper lobe pulmonary vein.
- Patients who did not attend any follow-up visits after hospital discharge.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
G.V.M.Carint Hospital
Myszków, Poland
Not Yet Recruiting
2
Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim
Oświęcim, Poland
Not Yet Recruiting
3
Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok
Sanok, Poland
Not Yet Recruiting
4
Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
Tychy, Poland
Actively Recruiting
5
Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group
Ustroń, Poland
Not Yet Recruiting
6
Dr. Tytus Chałubiński County Hospital
Zakopane, Poland
Not Yet Recruiting
Research Team
K
KaDirr Shemsi
CONTACT
J
Jiaxuan Fu
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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