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Patent Foramen OvaleNCT06120270

CeraFlex PFO Closure System PMCF Study

An observational study of Patent Foramen Ovale, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 15 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Patent Foramen Ovale
What is being tested?
CeraFlex PFO Closure System
Type of treatment
Medical device
How many people
180 participants
Where
15 sitesin 2 countries
Study dates
3 Nov 2023to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with PFO and need non-surgical closure of PFO.

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.
  • 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.

Trial locations and contacts

15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Kadir Shemsi, CTM contact

+86-176-2130-9203

Kadirr@lifetechmed.com

15 sites in 2 countries

Germany10 sites, 10 recruiting

  • Kardiologisch-Angiologische Praxis - Herzzentrum Bremen

    Bremen

    Martin Gödde, Dr

    Recruiting

  • Heart Center Dresden

    Dresden

    Felix Woitek, Dr

    Not yet recruiting

  • Hospital Fürth

    Fürth

    Rittger, Prof

    Recruiting

  • Kath. Marienkrankenhaus gGmbH

    Hamburg

    Dimitry Schewel, Dr

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg

    Daniel Kalbacher, Dr.

    Recruiting

  • German Heart Center Leipzig

    Leipzig

    Marcus Sandri, Dr

    Recruiting

  • Klinikum St. Georg gGmbH Leipzig

    Leipzig

    Norbert Klein, Dr

    Not yet recruiting

  • German Heart Center Munich

    Munich

    Stanimir Georgiev, Dr

    Recruiting

  • Herzzentrum Trier

    Trier

    Nikos Werner, Prof.

    Recruiting

  • University clinic Tübingen

    Tübingen

    Michal Droppa, Dr

    Recruiting

Other trials in Germany

South Korea5 sites, 5 recruiting

  • Yeungnam University Medical Center

    Daegu

    Jong Il Park, 010-4131-7090, happypji@ymc.yu.ac.kr

    Recruiting

  • Chonnam National University Hospital

    Gwangju, Gwangju, 57393

    Juhan Kim, 010-3629-0220, drfrog@cnuh.com

    Recruiting

  • ASAN Medical Center

    Seoul

    Yong Hyun Kim, 010-9570-9700, xkyhx@hanmail.net

    Recruiting

  • Samsung Medical Center

    Seoul

    Jinyoung Song, 010-8618-1798, amyjys@naver.com

    Recruiting

  • Catholic University of Korea St. Vincent's Hospital

    Suwon

    Sung Ho Her, 010-7731-0052, hhhsungho@naver.com

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
CeraFlex PFO Closure System
Keywords
Lifetech, Patent Foramen Ovale, PFO, CeraFlex, CeraFlex PFO, CeraFlex PFO Closure System
Medical subject headings
Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeraFlex PFO Closure SystemDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Residual shunt

    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.

    Measured: At procedure, 6 months and 12 months post-implantation

  2. Rate of stroke related events

    Ischemic stroke, cryptogenic stroke, or TIA

    Measured: From attempted procedure up to 24 months post-implantation

  3. Rate of Device Deficiencies

    Including device malfunctions, failures, and non-conformances

    Measured: From attempted procedure up to 24 months post-implantation

  4. Incidence of Serious Adverse Event

    SAE

    Measured: From attempted procedure up to 24 months post-implantation

  5. Incidence of death

    Death

    Measured: From attempted procedure up to 24 months post-implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start3 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120270
Sponsor's protocol ID
LT/TS/276I-2023-01
Status last verified
Jun 2026
First submitted
24 Oct 2023
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Patent Foramen Ovale, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kadir Shemsi, CTM (+86-176-2130-9203, Kadirr@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success rate (time frame: Procedure/at discharge or 7 days post-procedure, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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