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CeraFlex PFO Closure System PMCF Study

Recruitingn/aAges 18 Years - 85 YearsAllLifetech Scientific (Shenzhen) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 \& Device Size Selection: 1. Measure the distance from the defect to the aorta root; 2. 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. 3. Patients who are willing to comply with all study procedures and be available for the duration of the study. 4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent. Exclusion Criteria: 1. Age \<18 years or Age \>85 years. 2. Patient with a history of ongoing Atrial Fibrillation (AF). 3. Patient with malignancy or other illness where life expectancy is less than 1 year. 4. Patient not covered by a social security scheme. 5. Patients who are participating in an investigational drug or device study currently. 6. Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion). 7. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. 8. Any contraindication mentioned in the corresponding IFU: 1. 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. 2. 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. 3. Patients whose heart or vein size is too small to allow TEE probing or catheterization. 4. Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization. 5. Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement. 6. Patients whose heart does not have enough tissue to secure the device. 7. Patients with hypercoagulation disease. 8. 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.
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What it tests

  • CeraFlex PFO Closure System
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Where

15 sites
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
Bremen, Germany
Heart Center Dresden
Dresden, Germany
Hospital Fürth
Fürth, Germany
Kath. Marienkrankenhaus gGmbH
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
German Heart Center Leipzig
Leipzig, Germany
Klinikum St. Georg gGmbH Leipzig
Leipzig, Germany
German Heart Center Munich
Munich, Germany

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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