RecruitingOBSERVATIONAL

CeraFlex PFO Closure System PMCF Study

This study is gathering real-world information about a medical device called the CeraFlex PFO Closure System. This device is designed to close a small, naturally occurring hole in the heart called a Patent Foramen Ovale (PFO), which some people have. The main goal is to understand how effective the device is and how patients fare after receiving it. We're looking at things like how successfully the procedure goes and how patients feel over time. This isn't testing a new treatment, but rather observing how an approved device performs in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrolment target

180

Start

03 Nov 2023

Estimated completion

01 Dec 2028

Patent Foramen Ovale

What is this study about?

This study is called the CeraFlex PFO Closure System PMCF Study. PFO stands for Patent Foramen Ovale, which is a small opening between the upper chambers of the heart that everyone has before birth, but usually closes shortly after. For some people, it stays open, and while often harmless, in certain cases, doctors might suggest closing it, especially if someone has had unexplained strokes or severe migraines.

The CeraFlex PFO Closure System includes a small device, similar to an umbrella, that doctors use to close this PFO without major surgery. The purpose of this study is to collect information from people who have this device fitted in their everyday medical care. We want to see how well the device works and how patients are doing after the procedure, gathering real-life experiences and results. It's about making sure the device continues to perform as expected and understanding its impact on patients.

This study will follow patients for two years after their procedure. This allows doctors to gather a lot of important information about the device's long-term performance and the health outcomes for the patients. The information collected will help improve our understanding of this treatment.

Key takeaways

This study evaluates an existing heart device called the CeraFlex PFO Closure System.
It aims to understand how well the device works in real-world patients.
You would only be considered if you have a PFO linked to conditions like unexplained stroke or severe migraines.
Participation involves receiving the device and attending follow-up appointments over two years.
This is not a trial of an experimental treatment, but an observation of an approved device.

Who may be eligible?

To be considered for this study, you would typically need to have a confirmed Patent Foramen Ovale (PFO), which is a small hole in your heart. This PFO would also need to be linked to certain health issues, such as ongoing migraines or headaches, or if you've had a mini-stroke (TIA) or a stroke where the cause wasn't clear. Your doctor will carefully check your heart's anatomy to make sure the CeraFlex device can fit safely and effectively.

There are also some important requirements about who can take part. You need to be between 18 and 85 years old. You must be willing to attend all scheduled appointments and follow the study's instructions, and you or a legal guardian must be able to understand and sign a consent form. You cannot be pregnant or planning to become pregnant during the study period.

Some things would prevent you from joining. For example, if you have a history of certain heart rhythm problems (like ongoing Atrial Fibrillation), if you have a serious illness that means you might not live for at least another year, or if you are already taking part in another medical study involving an experimental drug or device. Also, if you have blood clots in your heart or certain serious bleeding disorders, or if the device wouldn't fit correctly due to your heart's structure, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed PFO (hole in my heart)?
Has my doctor linked my PFO to conditions like migraines or unexplained stroke/TIA?
Am I between 18 and 85 years old?
Am I able and willing to attend all follow-up appointments for two years?
Am I not currently pregnant or planning to become so during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have the CeraFlex PFO Closure System fitted as part of your standard medical care. After the procedure, you will have several follow-up appointments. These will happen when you're discharged from the hospital, then again at 1-3 months, 6 months, 12 months, and finally at 24 months (2 years) after getting the device. During these visits, doctors will check how you are doing, how the device is working, and generally monitor your health. The total time you'll be involved in the study, including all follow-ups, is 24 months, which is two years.

Potential risks and benefits

Participating in this study means you will receive a commonly used treatment (the PFO closure device) as part of your normal care, which aims to address your specific health condition. The study itself doesn't introduce new risks beyond those associated with the standard procedure. All medical procedures carry some risks, which your doctor will explain in detail, but receiving this device could potentially help with your migraines or reduce the risk of future strokes if your PFO is linked to these issues. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
Verified postcode
Bremen, Germany· Recruiting
Heart Center Dresden
Verified postcode
Dresden, Germany· Not yet recruiting
Hospital Fürth
Verified postcode
Fürth, Germany· Recruiting
Kath. Marienkrankenhaus gGmbH
Verified postcode
Hamburg, Germany· Recruiting
Universitätsklinikum Hamburg-Eppendorf (UKE)
Verified postcode
Hamburg, Germany· Recruiting
German Heart Center Leipzig
Verified postcode
Leipzig, Germany· Recruiting
Klinikum St. Georg gGmbH Leipzig
Verified postcode
Leipzig, Germany· Not yet recruiting
German Heart Center Munich
Verified postcode
Munich, Germany· Recruiting
Herzzentrum Trier
Verified postcode
Trier, Germany· Recruiting
University clinic Tübingen
Verified postcode
Tübingen, Germany· Recruiting
Chonnam National University Hospital
Verified postcode
Gwangju, South Korea· Recruiting
Yeungnam University Medical Center
Verified postcode
Daegu, South Korea· Recruiting

Common questions

What is a PFO?

A PFO (Patent Foramen Ovale) is a small, natural opening in the wall between the two upper chambers of your heart that didn't close completely after birth. Many people have one and never know.

What is the CeraFlex PFO Closure System?

It's a medical device, like a small, soft plug or 'umbrella', that doctors use to close that small opening (PFO) in your heart without needing major open-heart surgery.

Why is this study being done?

This study aims to collect real-world information about how well the CeraFlex system works and how patients feel after getting it. It helps doctors understand its performance in everyday use.

Will I get a new or experimental treatment?

No, you will receive the CeraFlex PFO Closure System, which is an approved device already available for use. This study is observing its performance, not testing something new.

How long will I be followed up in the study?

If you join, you'll be followed for 24 months, or two years, after the procedure to check on your health and the device's performance.

How to find out more

Kadir Shemsi, CTM

kadirr@lifetechmed.com +86-176-2130-9203 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.