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Boston Scientific, the developer of the innovative WATCHMAN FLX device that reduces the risk of stroke for atrial fibrillation patients, has chosen Mon Health Medical Center as the first hospital to participate in a new CHAMPION-AF clinical trial. This is a randomized head-to-head trial designed to evaluate the safety and effectiveness of the WATCHMAN FLX device compared to blood thinners.
Many patients with AFib are at risk for a stroke when blood clots form in a small pouch of the left atrium known as the left atrial appendage.
Boston Scientific produces the FDA approved WATCHMAN FLX device, which reduces the risk of stroke by addressing the issue and eliminating the need for long term blood thinners.
The device will be compared to non-vitamin K antagonist oral anticoagulants, considered the leading contemporary drugs for stroke risk reduction.
“We are pleased to participate in this important study that will evaluate whether a one-time WATCHMAN FLX procedure is equally effective as blood thinning medication as a first-line treatment for a wider population of patients with non-valvular AFib,” said Dr. Wissam Gharib, structural heart cardiologist at the Mon Health Heart & Vascular Center.
“A positive outcome from the CHAMPION-AF trial may put this device on equal footing with drug therapy for stroke risk reduction and offer an alternative for more patients who would otherwise face lifelong use of blood thinners and the associated risk of serious bleeding.”
The trial will study 3,000 patients suitable for oral anticoagulation across a broad spectrum of bleeding risk.
Patients at roughly 150 global sites, including Mon Health Medical Center, will be randomized to receive either the WATCHMAN FLX device or a NOAC and be evaluated for rates of stroke, bleeding and other major adverse events over five years.
Mon Health’s Heart and Vascular team of physicians and nurses are dedicated to the treatment of arrhythmias and structural heart disease. Cardiologists at Mon Health Medical Center were the first in West Virginia and the region to implant the WATCHMAN FLX device and today are among the nation’s leading specialists in the field.
For more information on the heart and vascular team, visit MonHealth.com/HEART.
To learn more about Boston Scientific and the CHAMPION-AF trial, visit BostonScientific.com.
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