Actively Recruiting
CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2026-01-26
180
Participants Needed
15
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are gathering real-world information on patient outcomes and evaluating the performance and success of the CeraFlex15 PFO Closure System, a device designed to close Patent Foramen Ovale (PFO) without surgery. This multicenter, prospective, observational study is open-label and post-market, aiming to understand how well this device works in everyday medical practice. Participants will receive the Lifetech CeraFlex PFO closure system, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The device is applied through a catheter-based procedure to close the PFO. After enrollment over about 18 months, each participant will be followed for 24 months after the procedure to monitor outcomes and device performance. Throughout the study, participants will have assessments at hospital discharge, then at 1 to 3 months, 6 months, 12 months, and 24 months post-procedure. Data on procedural success, residual shunt, stroke events, device issues, serious adverse events, and death will be collected and analyzed. An electronic data capture system will be used to securely collect study information.
CONDITIONS
Brief 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 according to the device's instructions for use
- Associated with recurrent migraine/headache, transient ischemic attack, or cryptogenic stroke
- Device size selection consistent with anatomical measurements
- Willing to comply with all study procedures and available for study duration
- Able and willing to provide informed consent or have a legally authorized representative do so
You will not qualify if you...
- Age under 18 years or over 85 years
- History of ongoing atrial fibrillation
- 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 or plan to become pregnant during the study
- Any condition increasing risk or preventing full compliance with the study
- Contraindications such as intracardiac thrombi, bleeding disorders, unsuitable heart or vein anatomy, active infections, hypercoagulation disease, or device size exceeding anatomical limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of procedure
Participants undergo the non-surgical closure of Patent Foramen Ovale (PFO) using the CeraFlex PFO Closure System device.
1 procedure visit (in-person)
Duration - 24 months post-procedure
Participants are monitored through follow-up visits to assess procedural success and collect data on patient outcomes.
Visits at discharge, 1 to 3 months, 6 months, 12 months, and 24 months post-procedure
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
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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