Active not recruitingNAINTERVENTIONAL

Amplatzer Amulet LAAO vs. NOAC

This research is looking into two ways of preventing strokes in people with atrial fibrillation, an irregular heartbeat. One way is using a small device called the Amplatzer Amulet to seal off a part of the heart called the left atrial appendage, where blood clots often form. The other way is by taking regular blood-thinning medications called NOACs. Researchers want to find out if the device is as safe and effective as the medication for people who are at high risk of stroke and are usually advised to take NOACs long-term. This study will involve people being randomly chosen to receive either the device or the medication, and then closely monitored.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

2,650

Start

07 Jul 2020

Estimated completion

01 Apr 2031

Atrial Fibrillation Stroke Bleeding

What is this study about?

This study is about helping people with a common heart condition called atrial fibrillation (AF). If you have AF, your heart beats irregularly, and this can make it more likely for blood clots to form in a small pouch in your heart called the left atrial appendage. If these clots travel to your brain, they can cause a stroke. To prevent strokes, doctors often prescribe blood-thinning medications, known as NOACs, which help stop blood clots from forming.

However, some people might prefer not to take blood thinners long-term, or they might have problems with them. This study is comparing NOACs with a different approach: a small device called the Amplatzer Amulet. This device is designed to seal off the left atrial appendage, preventing clots from escaping and causing a stroke. The main goal is to see if using this device is a safe and effective alternative to taking NOAC medications for people who are at a higher risk of stroke.

By comparing these two treatments, doctors hope to learn which option gives the best balance of safety and stroke prevention for people living with atrial fibrillation.

Key takeaways

Compares a heart device (Amplatzer Amulet) with blood-thinning medicines (NOACs) for stroke prevention.
Aims to see which treatment is safer and more effective for people with atrial fibrillation.
Participants will be randomly chosen for either the device or medication group.
You must be 18 or older and at high risk of stroke due to atrial fibrillation.
Regular follow-up appointments are a key part of the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have been diagnosed with atrial fibrillation, which is an irregular heartbeat. Your doctor would also need to have identified you as being at a higher risk of having a stroke, and would usually recommend you take blood-thinning medication long-term.

Key things include being 18 or older, and being able to attend all the necessary check-ups and appointments. You should also be able to take the study medications if you are assigned to that group, or be suitable for the device procedure if you are assigned to the device group.

However, you wouldn't be able to join if you already take blood thinners for other health reasons, or if you've recently had certain heart surgeries or have particular heart problems like mechanical heart valves. Also, if you're seriously allergic to common medications like aspirin or the blood thinners used in the study, you wouldn't be suitable.

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?
Has your doctor told you that you are at a high risk of stroke?
Could you potentially take blood-thinning medicine long-term?
Are you 18 years old or older?
Are you able to attend all necessary follow-up appointments?
Have you recently had (or are you planning) major heart surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: either receiving the Amplatzer Amulet device or taking a standard blood-thinning medication (NOAC). This is like flipping a coin to decide, making sure the comparison is fair.

If you receive the device, you'll have a procedure to implant it, and you'll be given specific instructions on medications to take afterwards. If you're in the medication group, you'll start taking the prescribed NOAC. In both groups, you'll have regular follow-up visits and assessments with the study team. These visits will help doctors monitor your health, check how well the treatment is working, and look for any side effects. The total length of your participation, including all follow-ups, will be clearly explained to you before you start.

Potential risks and benefits

Participating in research studies like this means you might receive a different treatment than you would usually get. A potential benefit could be that the treatment you receive is very effective for you, or it could lead to better knowledge that helps future patients. However, there are also potential risks involved, such as side effects from medications or complications from a procedure. The study team will explain all known risks and discomforts to you in detail. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (127)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital - Univ. of Alabama at Birmingham (UAB)
Verified postcode
Birmingham, United States
Heart Center Research, LLC
Verified postcode
Huntsville, United States
Arizona Cardiovascular Research Center
Verified postcode
Phoenix, United States
Tucson Medical Center
Verified postcode
Tucson, United States
Arrhythmia Research Group
Verified postcode
Jonesboro, United States
UAMS Medical Center
Verified postcode
Little Rock, United States
Scripps Health
Verified postcode
La Jolla, United States
Kaiser Permanente Los Angeles Medical Center
Verified postcode
Los Angeles, United States
Huntington Memorial Hospital
Verified postcode
Pasadena, United States
Mercy Medical Group - Cardiology
Verified postcode
Sacramento, United States
South Denver Cardiology Associates PC
Verified postcode
Littleton, United States
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States

Common questions

What is atrial fibrillation?

It's a common heart condition where your heartbeat is irregular, increasing your risk of stroke.

What is a NOAC?

NOACs are modern blood-thinning medicines that help prevent blood clots and reduce the risk of stroke.

How is the Amplatzer Amulet device put in?

It's usually inserted during a procedure using a thin tube (catheter) through a blood vessel, without open-heart surgery.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to either the device or the medication group, like drawing lots.

What happens if I change my mind after joining?

You can leave the study at any time, and this will not affect your usual medical care.