CeraFlex PFO Closure System PMCF Study

LifeTech Scientific

Status: Enrolling

Conditions: Patent Foramen Ovale

Treatments: Device: CeraFlex PFO Closure System

Study type: Observational

Funder types: Industry

Identifiers

NCT06120270

LT/TS/276I-2023-01

Details and patient eligibility

About

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.

Full 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 Occluder, and b) SteerEase Introducer. The PFO Closure System is indicated for the non-surgical closure of Patent Foramen Ovale (PFO), and the study objective is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex PFO Closure System.

The estimated enrollment period is approximately 18 months, and each subject will followed 24 months post-procedure. The assessment schedule at discharge, 1-3 months follow-up, 6 months follow-up, 12 months follow-up, and 24 months follow-up.

Electronic Date Capture (EDC) System will be used for this Study.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.