Evaluating the CeraFlex PFO Closure System for treating Patent Foramen Ovale

CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study

This study is testing the CeraFlex PFO Closure System to see how well it helps people with a heart condition called Patent Foramen Ovale feel better after the procedure.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 15 sites (Bremen and 14 other locations)
• Trial ID: NCT06120270 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with a confirmed PFO associated with recurrent migraines, TIAs, or cryptogenic strokes who meet specific anatomical and consent criteria.

Not a fit: Patients under 18 or over 85 years old, those with ongoing Atrial Fibrillation, or those with a life expectancy of less than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the CeraFlex PFO Closure System for patients with PFO.

How similar studies have performed: While this study is focused on a specific device, similar observational studies have shown success in evaluating PFO closure methods, indicating potential for positive outcomes.

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.

Where this trial is running

Bremen and 14 other locations

• Kardiologisch-Angiologische Praxis - Herzzentrum Bremen — Bremen, Germany (Recruiting)
• Heart Center Dresden — Dresden, Germany (Not_yet_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)
• Klinikum St. Georg gGmbH Leipzig — Leipzig, Germany (Not_yet_recruiting)
• German Heart Center Munich — Munich, Germany (Recruiting)
• Herzzentrum Trier — Trier, Germany (Recruiting)
• University clinic Tübingen — Tübingen, Germany (Recruiting)
• Yeungnam University Medical Center — Daegu, South Korea (Not_yet_recruiting)
• Chonnam National University Hospital — Gwangju, South Korea (Not_yet_recruiting)
• ASAN Medical Center — Seoul, South Korea (Not_yet_recruiting)
• Samsung Medical Center — Seoul, South Korea (Not_yet_recruiting)
• Catholic University of Korea St. Vincent's Hospital — Suwon, South Korea (Not_yet_recruiting)

Study contacts

• Principal investigator: Marcus Sandri, Dr — German Heart Center Leipzig
• Study coordinator: Kadir Shemsi, CTM

Conditions Patent Foramen Ovale; Lifetech; PFO; CeraFlex; CeraFlex PFO; CeraFlex PFO Closure System