Clinical trial NCT06120270: CeraFlex PFO Closure System PMCF Study
Official title: CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patent Foramen Ovale
Keywords: Lifetech
Patent Foramen Ovale
PFO
CeraFlex
CeraFlex PFO
CeraFlex PFO Closure System
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PFO and need non-surgical closure of PFO.

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.

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.

Primary outcomes:
measure: Procedural success rate
timeFrame: Procedure/at discharge or 7 days post-procedure, whichever comes first
Secondary outcomes:
measure: Residual shunt
timeFrame: At procedure, 6 months and 12 months post-implantation
measure: Rate of stroke related events
timeFrame: From attempted procedure up to 24 months post-implantation
measure: Rate of Device Deficiencies
timeFrame: From attempted procedure up to 24 months post-implantation
measure: Incidence of Serious Adverse Event
timeFrame: From attempted procedure up to 24 months post-implantation
measure: Incidence of death
timeFrame: From attempted procedure up to 24 months post-implantation
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
city: Dresden
country: Germany
facility: Heart Center Dresden
city: Fürth
country: Germany
facility: Hospital Fürth
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus gGmbH
city: Leipzig
country: Germany
facility: German Heart Center Leipzig
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH Leipzig
city: Munich
country: Germany
facility: German Heart Center Munich
city: Tübingen
country: Germany
facility: University clinic Tübingen
Study officials:
affiliation: German Heart Center Leipzig
name: Marcus Sandri, Dr
role: PRINCIPAL_INVESTIGATOR
References: