CHAMPION-AF Clinical Trial

Why CHAMPION-AF?

The CHAMPION‑AF clinical trial aims to expand WATCHMANTM as a first-choice option versus blood thinners to more Atrial Fibrillation (AFib)* patients.

With over 150,000 people successfully treated, this one time, FDA‑approved alternative to blood thinners offers a lifetime of safe and effective protection against stroke.

  

Who May Qualify for CHAMPION-AF?

CHAMPION-AF may be appropriate for patients who have been diagnosed with AFib, not caused by a heart valve problem, and have been deemed suitable for long term blood thinner therapy.
Although people of color have a lower prevalence of AFib, those diagnosed are 1.5 to 2 times more likely than Caucasians to experience an AFib related stroke.1 
  

What is Required of Me in the Trial?

doctor and patient looking at document

By joining this study:

  • You may have the opportunity to receive the WATCHMAN FLXTM Implant. 
  • You will be expected to visit your study doctor for required screenings. 
  • You will be required to attend follow‑up visits once a year, for up to five years. Some follow‑up appointments may be available virtually.
  

Is the CHAMPION‑AF Trial Right for Me?

For more information, review the brochure and make an appointment with your heart doctor to see if CHAMPION‑AF is right for you.
  
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.

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

1. Kabra R, Cram P, Girotra S, Vaughan Sarrazin M. Effect of Race on Outcomes (Stroke and Death) in Patients >65 Years with Atrial Fibrillation. Am J Cardiol. 2015;116:230–235. doi: 10.1016/j.amjcard.2015.04.012.


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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