CeraFlex PFO Closure System PMCF Study (NCT06120270) | Clinical Trial Compass
RecruitingNot Applicable
CeraFlex PFO Closure System PMCF Study
Germany, South Korea180 participantsStarted 2023-11-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU):
. Confirmed PFO by medical examinations;
. Associated with recurrent migraine/headache or TIA or cryptogenic stroke.
. Patient characteristics consistent with the corresponding IFU \& Device Size Selection:
. Measure the distance from the defect to the aorta root;
. Measure the distance from the defect to the superior vena cava (SVC) rim; select a device with the radius of the right disc that will not exceed the lesser of these two distances.
. Patients who are willing to comply with all study procedures and be available for the duration of the study.
. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
Exclusion criteria
. Age \<18 years or Age \>85 years.
. Patient with a history of ongoing Atrial Fibrillation (AF).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural success rate
Timeframe: Procedure/at discharge or 7 days post-procedure, whichever comes first