Status:
RECRUITING
CeraFlex PFO Closure System PMCF Study
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Patent Foramen Ovale
Eligibility:
All Genders
18-85 years
Brief 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.
Detailed Description
This is a multicenter, prospective, observational, single-arm, open-label, post-market Study. The study device is the Lifetech CeraFlex PFO closure system, which is composed of a) CeraFlex PFO Occlude...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients who are participating in an investigational drug or device study currently.
- Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion).
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- Any contraindication mentioned in the corresponding IFU：
- Patients known to have intracardiac thrombi, especially left atrial or left atrial appendage thrombi, demonstrated by echocardiography. Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.
- Anatomy in which the CeraFlexTM PFO device of the required size would interfere with intra-cardiac structure or intra-vascular structure, such as a pulmonary vein, or aorta root.
- Patients whose heart or vein size is too small to allow TEE probing or catheterization.
- Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization.
- Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
- Patients whose heart does not have enough tissue to secure the device.
- Patients with hypercoagulation disease.
- Any patient for whom the radius of the device is greater than the distance from the patent foramen ovale to the aortic root or superior vena cava.
- No contraindications specified in the SteerEase introducer IFU.
Key Trial Info
Start Date :
November 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06120270
Start Date
November 3 2023
End Date
December 1 2028
Last Update
July 8 2025
Active Locations (10)
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1
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
Bremen, Germany
2
Heart Center Dresden
Dresden, Germany
3
Hospital Fürth
Fürth, Germany
4
Kath. Marienkrankenhaus gGmbH
Hamburg, Germany