Active not recruitingNAINTERVENTIONAL

Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

This study is investigating a new method to help prevent strokes in some people with atrial fibrillation (AF). AF is a condition that makes the heart beat irregularly, which can lead to blood clots forming and causing a stroke. Even when taking blood-thinning medicines, some AF patients are still at high risk. This study will look at a device called the Vine™ Embolic Protection System. It's a small, permanent filter placed in the main arteries in the neck (carotid arteries) that supply blood to the brain. The idea is that this filter could catch tiny blood clots before they reach the brain and cause a stroke. Researchers want to ensure the device is safe and works well for patients who are at an ongoing high risk of stroke.

At a glance

Status

Active not recruiting

Phase

Sponsor

Javelin Medical

Enrolment target

100

Start

15 Apr 2019

Estimated completion

24 Oct 2027

Atrial Fibrillation Stroke

What is this study about?

If you have atrial fibrillation (AF), you'll know that it increases your risk of having a stroke. This is because AF can cause blood clots to form in your heart, which can then travel to your brain and block blood flow. To reduce this risk, doctors often prescribe blood-thinning medicines, also known as oral anticoagulants.

However, for some people with AF, even with blood thinners, the risk of stroke remains high. This study is exploring a new way to offer extra protection. It involves a small, permanent filter called the Vine™ Embolic Protection System. This filter would be placed in the main arteries in your neck (called the carotid arteries) that carry blood to your brain. The filter is designed to catch tiny blood clots bigger than 1.4mm, stopping them from reaching your brain and potentially causing a stroke. These types of clots are responsible for many strokes in people with AF.

The researchers want to make sure this device is both safe and effective for people who are at a higher risk of stroke despite taking their blood-thinning medication. By taking part, you would help doctors understand if this new filter could be a valuable extra step in preventing strokes for people like you.

Key takeaways

This study is testing a new device to prevent strokes in people with atrial fibrillation.
The device is a tiny filter placed in the neck arteries.
It's for people already taking blood thinners but still at high stroke risk.
You would continue your blood thinners if you join the study.
The study aims to check if the filter is safe and effective.

Who may be eligible?

This study is looking for volunteers who have atrial fibrillation (AF) and are already taking blood-thinning medicines. To be considered, you must have had a previous stroke or a 'mini-stroke' (TIA) and your doctor considers you to be at a high risk for another stroke. You also need to be over 50 years old.

There are certain health conditions that might mean you can't join. For example, if you have severe narrowing in your neck arteries, a history of bleeding in the brain, or issues with blood clotting, you wouldn't be able to take part. Also, if you are pregnant, planning to get pregnant, or have an allergy to metals like nickel or titanium, this study wouldn't be suitable for you.

Finally, the doctors will need to check the size and health of your neck arteries to make sure the filter can be safely put in. They will also need to ensure you can attend all the follow-up appointments, which are an important part of the study.

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 you have atrial fibrillation?
Have you had a stroke or TIA (mini-stroke) before?
Are you currently taking blood-thinning medication?
Are you over 50 years old?
Do you have any severe narrowing in your neck arteries?

Answer every question to see your result.

What does participation involve?

If you join this study, you would have an operation to place the Vine™ filter in both of your neck arteries (carotid arteries). This filter is designed to stay in permanently. You would continue to take your prescribed blood-thinning medication throughout the study.

The study involves several visits and assessments to monitor your health and the performance of the device. These would include regular check-ups, scans (like ultrasound) of your neck arteries, and tests to see how you are doing. The doctors will monitor you closely for any potential side effects or changes to your health. The total duration of your participation in the study would involve ongoing follow-up appointments.

Potential risks and benefits

Taking part in this study could potentially offer an additional way to reduce your risk of stroke, on top of your current blood-thinning medication. However, like any medical procedure, there are risks involved, such as those associated with the surgery to implant the device, or potential complications related to the device itself. You will be closely monitored for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

OLV Ziekenhuis
Verified postcode
Aalst, Belgium
ZNA Stuivenberg
Verified postcode
Antwerp, Belgium
Na Homolce Hospital
Verified postcode
Prague, Czechia
Alfried-Krupp Krankenhaus Rüttenscheid
Verified postcode
Essen, Germany
Cardio Vasculäres Centrum Frankfurt
Verified postcode
Frankfurt, Germany
Cardioangiologisches Centrum Bethanien
Verified postcode
Frankfurt, Germany
General Hospital of Athens "Hippokrateio"
Verified postcode
Athens, Greece
Laiko Hospital
Verified postcode
Athens, Greece
University General Hospital of Larisa
Verified postcode
Larissa, Greece
European Interbalkan Medical Center
Verified postcode
Thessaloniki, Greece
Gottsegen György Hungarian Institute of Cardiology
Verified postcode
Budapest, Hungary
Carmel
Verified postcode
Haifa, Israel

Common questions

What is atrial fibrillation?

Atrial fibrillation (AF) is a condition where your heart beats irregularly, which can increase your risk of stroke.

What is the Vine™ filter?

It's a tiny, permanent filter placed in a neck artery to catch blood clots before they reach the brain.

Do I stop taking my blood thinners?

No, you would continue to take your prescribed blood-thinning medication as usual.

Is the filter removed later?

No, the Vine™ filter is designed to stay in permanently once it's implanted.

What's a stroke?

A stroke happens when blood flow to part of your brain is interrupted, causing brain cells to die.