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New device aims to seal heart holes and prevent strokes

NCT ID NCT06120270

Disease control Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 180 people who receive the CeraFlex PFO Closure System, a device that closes a small hole in the heart called a patent foramen ovale (PFO). The goal is to see how well the device works in everyday medical practice, especially for patients with migraines or strokes linked to PFO. Researchers will track procedure success and any leftover shunts after the device is placed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CeraFlex PFO Closure System (a device implanted to close a hole in the heart)
What this could lead to
If successful, this could confirm that the CeraFlex device safely and effectively closes PFO, reducing the risk of stroke and migraine in patients.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove the device is better than other treatments. Risks include device complications or incomplete closure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patent foramen ovale

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASAN Medical Center

    RECRUITING

    Seoul, South Korea

  • Catholic University of Korea St. Vincent's Hospital

    RECRUITING

    Suwon, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, Gwangju, 57393, South Korea

  • German Heart Center Leipzig

    RECRUITING

    Leipzig, Germany

  • German Heart Center Munich

    RECRUITING

    Munich, Germany

  • Heart Center Dresden

    NOT_YET_RECRUITING

    Dresden, Germany

  • Herzzentrum Trier

    RECRUITING

    Trier, Germany

  • Hospital Fürth

    RECRUITING

    Fürth, Germany

  • Kardiologisch-Angiologische Praxis - Herzzentrum Bremen

    RECRUITING

    Bremen, Germany

  • Kath. Marienkrankenhaus gGmbH

    RECRUITING

    Hamburg, Germany

  • Klinikum St. Georg gGmbH Leipzig

    NOT_YET_RECRUITING

    Leipzig, Germany

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • University clinic Tübingen

    RECRUITING

    Tübingen, Germany

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    RECRUITING

    Hamburg, Germany

  • Yeungnam University Medical Center

    RECRUITING

    Daegu, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.