A device that could revolutionize treatment options for patients with atrial fibrillation is now available through a landmark clinical trial offered at Nebraska Medical Center.

The multi-center trial, called CHAMPION-AF, compares the novel WATCHMAN FLX device to traditional blood thinning medications for people with atrial fibrillation. WATCHMAN FLX is an improved version of the first generation WATCHMAN device, which available for people who cannot use blood thinners.

The CHAMPION-AF trial also offers WATCHMAN FLX to atrial fibrillation patients who can take blood thinners, which may allow them to eliminate blood thinners from their treatment regimen.

"This trial is the most significant cardiology trial of our generation as it has the potential to impact tens of millions of people and may totally change the way we treat atrial fibrillation," explains Andrew Goldsweig, MD, Nebraska Medicine interventional cardiologist. 

"For approximately 100 years, the use of blood thinners has been the gold standard treatment to prevent stroke in people with atrial fibrillation. While the WATCHMAN FLX device is FDA-approved for individuals with reasons to avoid blood thinners, the CHAMPION-AF offers the new WATCHMAN FLX device as a firstline therapy for all people with atrial fibrillation, whether they have issues with blood thinners or not."

This is significant because, blood thinners can prevent clot formation, but they also increase a person's bleeding risk. In addition, they can be expensive and have adverse interactions with other medications. The implant device seals off an area of the heart called the left atrial appendage where blood clots form. This helps prevent clots from entering the bloodstream and potentially causing a stroke. In patients who should not take blood thinners, the device was more effective than blood thinners, reducing the risk for stroke to less than 1% per year.

Atrial fibrillation is the most common cardiac arrhythmia. It increases the risk of developing blood clots inside the heart, which can cause stroke. People with atrial fibrillation are five times more likely to have a stroke than the general population. Atrial fibrillation occurs in 20% of men and 8% of women at some point in their lives.

WATCHMAN FLX has several new features that provide a significant improvement over the first-generation device. The new implant comes in a wider variety of sizes to accommodate nearly every body size, has improved stabilization anchors, and has a fully rounded design that allows doctors to safely adjust the device during implantation to ensure optimal placement.

A doctor places a tiny tube in a vein in the upper leg to implant the device, similar to a standard stent procedure. The doctor then guides the device into the left atrial appendage of the heart using X-ray and ultrasound guidance. Patients typically stay in the hospital overnight and leave the next morning. 

Nebraska Medical Center was the first hospital in Omaha to offer patients the first-generation WATCHMAN device in early 2018 and has implanted more than 120 devices with extremely positive results.

"We are internationally recognized leaders in this area," Dr. Goldsweig says. "We are very honored to be one of the hand-picked medical centers to participate in this trial." Nebraska Medicine has a specialized clinic to evaluate people with atrial fibrillation to determine if the WATCHMAN device is the right course of treatment.