CeraFlex PFO Closure System PMCF Study

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Nov 1, 2023

Keywords

ClinConnect Summary

The CeraFlex PFO Closure System PMCF Study is a clinical trial designed to gather real-world information about how well the CeraFlex™ device works for closing a small hole in the heart called a Patent Foramen Ovale (PFO). This study aims to see how successful the procedure is and how patients feel afterward, particularly those who have experienced migraines, transient ischemic attacks (TIAs), or strokes that cannot be explained by other causes. The trial is currently looking for participants aged 65 to 85 years who have been diagnosed with a PFO and meet specific health criteria.

To be eligible for this study, participants must have documented evidence of a PFO and the right medical background that suggests closure is needed. They should be willing to follow the study's guidelines and provide consent. Those who are not eligible include individuals under 18 or over 85, those with certain heart conditions, or anyone with serious illnesses that limit their life expectancy. Participants can expect to undergo procedures to close the PFO, and they will be monitored for their progress over time. Overall, this study aims to help improve treatment options for patients with PFO-related health issues.

Gender

ALL

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 \& 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.