Evaluating the CeraFlex PFO Closure System for treating Patent Foramen Ovale

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world data on patient outcomes following the use of the CeraFlex PFO Closure System, which is designed for the non-surgical closure of Patent Foramen Ovale (PFO). It is a multicenter, prospective, single-arm study that will follow patients for 24 months post-procedure, assessing their health at various intervals. The study will utilize an Electronic Data Capture (EDC) system to collect and analyze data on procedural success and device performance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
  Bremen, Germany Recruiting
• Hospital Fürth
  Fürth, Germany Recruiting
• Kath. Marienkrankenhaus gGmbH
  Hamburg, Germany Recruiting
• Universitätsklinikum Hamburg-Eppendorf (UKE)
  Hamburg, Germany Recruiting
• German Heart Center Leipzig
  Leipzig, Germany Recruiting
• German Heart Center Munich
  Munich, Germany Recruiting

Study contacts

• Principal investigator: Marcus Sandri, Dr — German Heart Center Leipzig
• Study coordinator: Kadir Shemsi, CTM
• Email: Kadirr@lifetechmed.com
• Phone: +86-176-2130-9203

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes after PFO closure at Severance Hospital

  This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.

  Recruiting Yonsei University · Seoul · NCT07724171

• P3 Occluder System for closing a heart opening (PFO) after stroke

  We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.

  Recruiting Recross Cardio, Inc. · Belgrade · NCT07698951

• PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner

  This study tests whether closing a patent foramen ovale (PFO) plus 24 weeks of prasugrel works better for long-term migraine relief than prasugrel alone in people whose migraines improve on blood-thinning therapy.

  Recruiting Phase 3 Columbia University · New York, New York · NCT07629635

• Comparing Cocoon vs Amplatzer PFO Occluders in Adults After Stroke or TIA

  This trial tests whether the Cocoon PFO Occluder works as well as the Amplatzer PFO Occluder in adults who had a cryptogenic stroke or TIA and have a PFO requiring closure.

  Recruiting Sahajanand Medical Technologies Limited · Bad Oeynhausen, North Rhine-Westphalia (Nordrhein-Westfalen) · NCT07380490

• Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

  This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

  Recruiting at 5 sites Recross Cardio, Inc. · Los Angeles, California and 4 other locations · NCT07172464

• Closing a PFO to improve glymphatic function and migraine symptoms

  This study will see if closing a patent foramen ovale (PFO) improves glymphatic system function and reduces migraine attacks in adults with PFO and migraine.

  Recruiting at 2 sites First Affiliated Hospital Xi'an Jiaotong University · Luoyang, Henan and 1 other locations · NCT07170176

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.