Active not recruitingNAINTERVENTIONAL

CHAMPION-AF Clinical Trial

The CHAMPION-AF study is looking for a new way to prevent strokes in people with a common heart condition called atrial fibrillation (AF). If you have AF, your heart beats irregularly, which can cause blood clots to form and lead to a stroke. Normally, blood-thinning medicines (called anticoagulants) are used to prevent these clots. This study wants to find out if a small device, called the WATCHMAN FLX, which is put into your heart to block off a small pouch where clots often form, works as well as these medicines. This could offer an alternative for people who might struggle with long-term medication.

At a glance

Status

Active not recruiting

Phase

Sponsor

Boston Scientific Corporation

Enrolment target

3,000

Start

15 Oct 2020

Estimated completion

01 Dec 2027

Atrial Fibrillation Stroke Bleeding

What is this study about?

The CHAMPION-AF study is investigating a new approach to stroke prevention for people aged 18 and over who have a specific type of irregular heartbeat called non-valvular atrial fibrillation (AF). This condition means your heart beats out of sync, which can make blood pool in a small pouch in your heart called the left atrial appendage. When blood pools there, it can form clots, and if these clots break off, they can travel to your brain and cause a stroke.

Currently, the main way to prevent these strokes is by taking blood-thinning medicines, also known as oral anticoagulants. These medicines help stop clots from forming. However, taking blood-thinners long-term isn't suitable for everyone, as they can increase the risk of bleeding. This study wants to see if a small device, called the WATCHMAN FLX, could be a good alternative.

The WATCHMAN FLX device is designed to seal off that little pouch in your heart where clots often form, aiming to prevent strokes without the need for lifelong blood-thinning medication. The study will compare how well this device works against the standard blood-thinning medicines. By taking part, you could help researchers understand if this device is a safe and effective option for many people with AF.

Key takeaways

This study compares a heart device to blood-thinning medicines for stroke prevention.
It's for people with a specific type of irregular heartbeat called atrial fibrillation.
The device aims to prevent clots without needing long-term blood thinners.
Participation involves being randomly assigned to receive either the device or medicine.
Close medical monitoring and regular check-ups are part of the study.
You can ask questions and withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have a specific type of irregular heartbeat called non-valvular atrial fibrillation. You would need to have a certain risk level for stroke, as assessed by your doctor, and be considered suitable for both the device procedure and the regular blood-thinning medications being tested in the study. You also need to be willing to clearly understand and sign a consent form, and be able to attend all required follow-up appointments.

There are also some reasons why you might not be able to join. For example, if you are already in another research study with treatments, or if you need blood-thinning medication for reasons other than your irregular heartbeat (like certain blood conditions). You also can't take part if you're allergic to blood-thinners or aspirin, or if you have certain other heart conditions or procedures planned in the near future, such as recent heart surgery or a cataract operation.

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.

Are you 18 years old or older?
Do you have an irregular heartbeat called atrial fibrillation (not caused by severe valve issues)?
Have you been told you're at a certain risk of stroke due to your atrial fibrillation?
Are you able and willing to attend all study appointments and understand the study information?
Do you need long-term blood-thinning medication for reasons other than your atrial fibrillation?
Are you able to take either the device or the blood-thinning medicines involved in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the CHAMPION-AF study, you would be randomly assigned to one of two groups. One group would receive the WATCHMAN FLX device, which involves a procedure to implant it. The other group would continue with or start taking a standard blood-thinning medicine. The study involves regular check-ups and assessments, which could include doctor visits, heart scans, and blood tests, to monitor your health and how well the treatment is working. The specific total duration and frequency of visits would be explained in full detail by the study team, but generally, clinical trials involve ongoing monitoring for a period of time to track long-term outcomes.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from close medical monitoring and access to a potentially new treatment. However, all medical procedures and medications carry potential risks. The WATCHMAN FLX device procedure has risks associated with any heart procedure, such as bleeding or infection, and blood-thinning medications also carry risks like increased bleeding. The study team will explain all known risks and potential benefits in detail so you can make an informed decision. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (141)

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

Grandview Medical Center
Verified postcode
Birmingham, United States
University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Arizona Arrhythmia Research Center
Verified postcode
Phoenix, United States
Phoenix Cardiovascular Research Group
Verified postcode
Phoenix, United States
Scottsdale Healthcare - Shea
Verified postcode
Scottsdale, United States
Tucson Medical Center Healthcare
Verified postcode
Tucson, United States
Arrythmia Research Group
Verified postcode
Jonesboro, United States
Sharp Chula Vista Medical Center
Verified postcode
Chula Vista, United States
Marin General Hospital
Verified postcode
Greenbrae, United States
Scripps Memorial Hospital
Verified postcode
La Jolla, United States
Los Robles Hospital and Medical Center
Verified postcode
Los Angeles, United States
El Camino Hospital
Verified postcode
Mountain View, United States

Common questions

What is atrial fibrillation?

It's an irregular and often very fast heartbeat. It can increase your risk of stroke.

What is the WATCHMAN FLX device?

It's a small device implanted in your heart to block a pouch where blood clots often form, aiming to prevent strokes.

What is a 'blood-thinning medicine'?

These are medicines, also called anticoagulants, that help prevent blood clots from forming. DOACs are a common type.

Who is funding this study?

This information isn't provided in the summary, but you can always ask the study team or your doctor about this.

What does 'non-valvular' atrial fibrillation mean?

It means your irregular heartbeat is not caused by severe problems with your heart valves, allowing other treatment options.