Active not recruitingNAINTERVENTIONAL

Abbott Medical - VERITAS Study

The VERITAS Study is testing a medical device called the Amulet™ 2 Left Atrial Appendage (LAA) Occluder. This device is designed for people who have an irregular heartbeat, known as atrial fibrillation (AF), which can increase their risk of having a stroke. The study aims to see how safe and effective the Amulet™ 2 device is at preventing strokes in people who cannot or choose not to take traditional blood-thinning medicines. If successful, this device could offer an alternative way to reduce stroke risk for these patients. Researchers want to make sure it works well and is safe for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

458

Start

07 Nov 2024

Estimated completion

01 Sep 2027

Atrial Fibrillation (AF)Stoke

What is this study about?

This study is called the VERITAS Study, and it's looking into a new treatment for people with a common heart condition called atrial fibrillation, or AF. If you have AF, your heart beats irregularly, which can sometimes lead to blood clots forming. These clots can then travel to your brain and cause a stroke. Usually, doctors prescribe blood-thinning medicines to prevent these clots.

However, some people cannot take blood thinners, or they might have reasons to prefer not to take them long-term. This study offers an alternative. It's testing a small device called the Amulet™ 2. This device is designed to be placed in a small pouch of the heart called the left atrial appendage (LAA), where most of these stroke-causing blood clots tend to form. By closing off this pouch, the device aims to stop clots from forming there and reduce your risk of stroke.

The main goal of the study is to see how well the Amulet™ 2 device works at preventing strokes and how safe it is for patients. Doctors will carefully monitor people who have the device to make sure it's doing its job and that there are no unexpected problems. This research will help the medical community understand if the Amulet™ 2 can be a good option for people with AF who need an alternative to blood thinners.

Key takeaways

Tests a new device (Amulet™ 2) for stroke prevention.
For people with irregular heartbeat (AF) and stroke risk.
An alternative to long-term blood thinners.
Aims to block where clots form in the heart.
Requires follow-up visits and temporary medication.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

This study might be for you if you have non-valvular atrial fibrillation – an irregular heartbeat not caused by a problem with your heart valves. You should also be at an increased risk of stroke but have good reasons not to take long-term blood-thinning medication. Your doctor will assess if you can stop blood thinners once the device is in place.

There are certain things that would mean you can't join the study. For example, if you've already had a repair for a hole in your heart, have a mechanical heart valve, or if certain medical procedures, like a specific type of scan (transesophageal echocardiography), are not safe for you. Also, if you've had major surgery or a heart procedure like ablation within the last month, or if you need to take certain anti-clotting medications for more than six months after the device would be put in, you wouldn't be able to participate. You also need to be 18 years old or older and willing to follow the study's instructions and attend follow-up appointments.

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 an irregular heartbeat (non-valvular atrial fibrillation)?
Am I at increased risk of stroke?
Do I have a good reason why I can't take or don't want to take long-term blood thinners?
Am I 18 years old or older?
Am I willing and able to attend follow-up appointments?
Have I had any recent major surgery or heart procedures in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main step involves a procedure to implant the Amulet™ 2 device into your heart's left atrial appendage. This is done in hospital. After the device is implanted, you will need to take a specific set of medications for a short period, as advised by your study doctor. You will have regular check-ups and appointments with the study team. These visits are important for your safety and to help doctors understand how well the device is working. The study team will explain exactly how many visits you'll need and what tests will be done at each one. You will be expected to attend all scheduled follow-up appointments to ensure your health is monitored and to gather all necessary information for the study.

Potential risks and benefits

Taking part in this study might offer the benefit of reducing your stroke risk without needing long-term blood-thinning medication, especially if other options aren't suitable for you. However, as with any medical procedure, there are potential risks, including those related to the implantation procedure itself and possible side effects from the device or medications. The study team will explain all known risks to you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

Arizona Arrhythmia Research Group
Verified postcode
Phoenix, United States
Arrhythmia Research Group
Verified postcode
Jonesboro, United States
Baptist Medical Center
Verified postcode
Jacksonville, United States
AdventHealth Orlando
Verified postcode
Orlando, United States
Northside Hospital
Verified postcode
Atlanta, United States
Kansas City Cardiac Arrhythmia Research Foundation
Verified postcode
Overland Park, United States
Henry Ford Providence Southfield Hospital
Verified postcode
Southfield, United States
Mayo Clinic
Verified postcode
Rochester, United States
CHI Health Creighton University Medical Center-Bergan Mercy
Verified postcode
Omaha, United States
NYU Langone Health
Verified postcode
New York, United States
Mount Sinai Hospital
Verified postcode
New York, United States
Roper Hospital
Verified postcode
Charleston, United States

Common questions

What is atrial fibrillation (AF)?

Atrial fibrillation (AF) is a common heart condition that causes an irregular and often abnormally fast heart rate.

What is the Amulet™ 2 device?

It's a small device designed to close off a part of your heart called the left atrial appendage (LAA) to prevent blood clots forming there and causing a stroke.

Why is this device being studied?

It's being studied as an alternative to blood-thinning medications for people with AF who are at risk of stroke but can't take or don't want to take those medicines long-term.

Will I need to take medications after getting the device?

Yes, you will need to take specific medications for a certain period after the device is implanted. Your doctor will explain this in detail.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.