Actively Recruiting
CeraFlex PFO Closure System PMCF Study
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2026-01-26
180
Participants Needed
15
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
CONDITIONS
Official Title
CeraFlex PFO Closure System PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed Patent Foramen Ovale (PFO) by medical examinations
- Indication for PFO occluder closure based on recurrent migraine/headache, transient ischemic attack (TIA), or cryptogenic stroke
- Patient characteristics matching the device instructions for use and appropriate device size selection
- Willingness to comply with all study procedures and availability for the study duration
- Ability to provide informed consent by the patient or legally authorized representative
You will not qualify if you...
- Age under 18 years or over 85 years
- History of ongoing atrial fibrillation (AF)
- Malignancy or illness with life expectancy less than 1 year
- Not covered by a social security scheme
- Currently participating in another investigational drug or device study
- Women of childbearing potential who are pregnant or plan to become pregnant during the study
- Any condition increasing risk or preventing full compliance with the study
- Contraindications from the device instructions for use, including intracardiac thrombi, bleeding disorders untreated for aspirin therapy, unsuitable anatomy interfering with device placement, inability to undergo catheterization, active infection, recent sepsis, insufficient heart tissue for device placement, hypercoagulation disease, or device size exceeding anatomical limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
Bremen, Germany
Actively Recruiting
2
Heart Center Dresden
Dresden, Germany
Not Yet Recruiting
3
Hospital Fürth
Fürth, Germany
Actively Recruiting
4
Kath. Marienkrankenhaus gGmbH
Hamburg, Germany
Actively Recruiting
5
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
Actively Recruiting
6
German Heart Center Leipzig
Leipzig, Germany
Actively Recruiting
7
Klinikum St. Georg gGmbH Leipzig
Leipzig, Germany
Not Yet Recruiting
8
German Heart Center Munich
Munich, Germany
Actively Recruiting
9
Herzzentrum Trier
Trier, Germany
Actively Recruiting
10
University clinic Tübingen
Tübingen, Germany
Actively Recruiting
11
Yeungnam University Medical Center
Daegu, South Korea
Not Yet Recruiting
12
Chonnam National University Hospital
Gwangju, South Korea
Not Yet Recruiting
13
ASAN Medical Center
Seoul, South Korea
Not Yet Recruiting
14
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
15
Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Not Yet Recruiting
Research Team
K
Kadir Shemsi, CTM
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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