CeraFlex PFO Closure System PMCF Study
Recruiting
Observational Study
Patent Foramen Ovale
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Observational
- Participants needed
- 180 (estimated)
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU):
1. Confirmed PFO by medical examinations;
2. Associated with recurrent migraine/headache or TIA or cryptogenic stroke.
2. Patient characteristics consistent with the corresponding IFU…
Contacts