CeraFlex PFO Closure System PMCF Study

NCT06120270 | Recruiting

• 1 other identifier: LT/TS/276I-2023-01
• Study Type: observational
• Target: 180
• Locations: 2 countries
• Sites: 15

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.

Conditions

Patent Foramen Ovale

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Procedural success rate

  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.

  Procedure/at discharge or 7 days post-procedure, whichever comes first

Secondary Outcomes (5)

• Residual shunt

  At procedure, 6 months and 12 months post-implantation

• Rate of stroke related events

  From attempted procedure up to 24 months post-implantation

• Rate of Device Deficiencies

  From attempted procedure up to 24 months post-implantation

• Incidence of Serious Adverse Event

  From attempted procedure up to 24 months post-implantation

• Incidence of death

  From attempted procedure up to 24 months post-implantation

Interventions

CeraFlex PFO Closure System DEVICE

The Lifetech CeraFlex™ PFO occluder device is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with PFO and need non-surgical closure of PFO.

You may qualify if:

• Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU):
• Confirmed PFO by medical examinations;
• Associated with recurrent migraine/headache or TIA or cryptogenic stroke.
• Patient characteristics consistent with the corresponding IFU \& Device Size Selection:
• Measure the distance from the defect to the aorta root;
• 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.
• Patients who are willing to comply with all study procedures and be available for the duration of the study.
• Patients or legally authorized representative(s) who are willing and capable of providing informed consent.

You may not qualify if:

• Age \<18 years or Age \>85 years.
• Patient with a history of ongoing Atrial Fibrillation (AF).
• Patient with malignancy or other illness where life expectancy is less than 1 year.
• Patient not covered by a social security scheme.
• Patients who are participating in an investigational drug or device study currently.
• Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion).
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
• Any contraindication mentioned in the corresponding IFU：
• 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.
• 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.
• Patients whose heart or vein size is too small to allow TEE probing or catheterization.
• Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization.
• Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Patients whose heart does not have enough tissue to secure the device.
• Patients with hypercoagulation disease.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (15)

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

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marcus Sandri, Dr

  German Heart Center Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kadir Shemsi, CTM

CONTACT

+86-176-2130-9203; Kadirr@lifetechmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 7, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

DE (10); KR (5)