CeraFlex PFO Closure System PMCF Study
ConditionPatent Foramen Ovale
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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 criteria
Qualifiers
Confirmed PFO by medical examinations;
Associated with recurrent migraine/headache or TIA or cryptogenic stroke.
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.
Disqualifiers
Age <18 years or Age >85 years.
Patient with a history of ongoing Atrial Fibrillation (AF).
Patient with malignancy or other illness where life expectancy is less than 1 year.
Patient not covered by a social security scheme.
Trial design
Treatments tested in this trial
- CeraFlex PFO Closure System
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov