CeraFlex PFO Closure System PMCF Study

Recruiting

• Conditions: Patent Foramen Ovale

• Registration Number: NCT06120270
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-11-01
• Study Start: 2023-11-03
• Study First Posted: 2023-11-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-12
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success rate	Procedure/at discharge or 7 days post-procedure, whichever comes first	Procedure success is defined as a composite of : 1. absence of peri-procedural stroke-related events (ischemic stroke, cryptogenic stroke, or TIA), device embolization, cardiac or vascular perforation, or death, at discharge or 7 days post-procedure, whichever comes first; 2. successful implantation of the device at the procedure.

Secondary Outcome Measures

Name	Time	Method
Rate of stroke related events	From attempted procedure up to 24 months post-implantation	Ischemic stroke, cryptogenic stroke, or TIA
Rate of Device Deficiencies	From attempted procedure up to 24 months post-implantation	Including device malfunctions, failures, and non-conformances
Incidence of Serious Adverse Event	From attempted procedure up to 24 months post-implantation	SAE
Residual shunt	At procedure, 6 months and 12 months post-implantation	Residual shunt was classified on the basis of the estimated number of microbubbles detected in the left atrium within three cardiac cycles after appearance in the right atrium, as observed on cTTE/cTEE while the patient was at rest or during Valsalva procedure. The presence of 0 microbubbles was classified as no shunt, 1 to 5 microbubbles as small, 6 to 25 microbubbles as moderate, and more than 25 microbubbles as large.
Incidence of death	From attempted procedure up to 24 months post-implantation	Death

Trial Locations

Locations (8)

Kardiologisch-Angiologische Praxis - Herzzentrum Bremen; 🇩🇪 Bremen, Germany

Hospital Fürth; 🇩🇪 Fürth, Germany

Heart Center Dresden; 🇩🇪 Dresden, Germany

German Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Klinikum St. Georg gGmbH Leipzig; 🇩🇪 Leipzig, Germany

German Heart Center Munich; 🇩🇪 Munich, Germany

University clinic Tübingen; 🇩🇪 Tübingen, Germany

Kath. Marienkrankenhaus gGmbH; 🇩🇪 Hamburg, Germany