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CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.