Atrial Fibrillation and Stroke

What is Atrial Fibrillation?

Atrial Fibrillation (AFib)* is a heart condition in which the upper chambers of your heart quiver. This condition can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). If a blood clot forms here, it can travel through an artery to the brain and cause a stroke.

People with AFib have a five‑times greater risk for stroke than people with normal heart rhythms.1

illustration of atrial fibrillation
  

Managing AFib and Stroke Risk

WATCHMAN vs Blood Thinners
Today, a number of treatments including blood thinner medication or Left Atrial Appendage Closure (LAAC) implants like WATCHMAN FLXTM are available to protect you from strokes related to your AFib.
The CHAMPION-AF clinical trial will compare WATCHMAN FLX to a category of blood thinners called non-vitamin K antagonist oral anticoagulation, or NOACs.

The study will research the safety and effectiveness of the WATCHMAN FLX device compared to treatment with NOAC therapy to determine its effectiveness in stroke risk reduction for patients with AFib not caused by a heart valve problem.

  

Understanding Left Atrial Appendage Closure Surgery with the WATCHMAN Implant

Watch the 4‑minute video to see how the WATCHMAN Implant works.
patient illustration
  
The Implant Procedure

Here's what happens during the procedure.

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Step 1

To implant the device, your doctor inserts a narrow tube into a vein in your upper leg.
Procedure Step 2
Step 2

Your doctor guides the device through the tube, into your left atrial appendage (LAA).
Procedure Step 3
Step 3

The procedure is typically done under general anesthesia and takes under an hour. People usually stay in the hospital overnight and go home the next day.
Procedure Step 4
Step 4

After the procedure, you will be on blood thinning medication, as prescribed by your study doctor.
Procedure Step 5
Step 5

Imaging of your heart will be performed 4 months after your procedure to see how well the heart tissue has grown over the implant.
  

Why CHAMPION-AF?

group of people smiling and looking happy
The CHAMPION-AF clinical trial aims to make FDA-approved WATCHMAN FLXTM a first-choice option versus blood thinners for stroke risk reduction in more patients with AFib.
Learn More
  
Complete Trial Discussion Guide

Talk to Your Doctor

For more information, or to find out if you're an appropriate candidate for the CHAMPION-AF clinical trial, fill out and print the simple trial discussion guide below, and bring it to a scheduled appointment with your heart doctor.

Trial Discussion Guide

* All mentions of 'AFib' or 'Atrial Fibrillation' specifically indicate atrial fibrillation, not caused by a heart valve problem.

1. Holmes D. Atrial Fibrillation and Stroke Management: Present and Future. Semin Neurol 2010, 30:528-536.
2. WatchUsNow.com. The Harris Poll online survey. Boston Scientific. SH-574213-AA.
https://www.watchusnow.com/?page=d75be9d4-ba36-456c-a72d-dc3df07892da. Accessed March 28, 2019.

Please talk to your physician about any additional risks related to the CHAMPION-AF trial.

Important Safety Information

The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.

With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. In rare cases death can occur.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device.

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