champion trial imageInova Heart and Vascular Institute Explores Implant's Potential to Replace Anticoagulants in AFib Stroke Prevention

Physicians at IHVI are investigating alternative solutions for AFib-related stroke prevention that reduce side effects and treatment-related costs, led by IHVI interventional cardiologist Matthew W. Sherwood, MD, MHS, Director of the IHVI LAAC/ WATCHMAN Program. Dr. Sherwood also serves as Co-Director of both the Structural Heart Program and the Cardiac Catheterization Laboratories at IFMC.

IHVI is participating in the CHAMPION-AF trial to compare a leading-edge heart implant device with traditional anticoagulant therapy. The results of this global clinical study could mean that patients with AFib might be able to discontinue daily blood thinner use, decreasing pill burden and increasing patient outcomes and satisfaction.

Millions of Americans have AFib, putting them at increased risk for ischemic stroke. Individuals with AFib are five times more likely to have a stroke than those without the condition. Daily oral anticoagulants are often prescribed to AFib patients to decrease stroke risk; however, blood thinners carry the risk of side effects like increased bleeding and bruising, in addition to the expense and inconvenience of daily prescription medication.

Reducing Stroke Risk Without Anticoagulants

IHVI's doctors were among the first in the region to offer the WATCHMAN device as an alternative to anticoagulant therapy for AFib patients. WATCHMAN is an FDA-approved implantable device that seals off the left atrial appendage – a primary source of embolization – and ultimately prevents blood clots and stroke. Because more than 90 percent of AFib strokes form in the LAA, this groundbreaking device could potentially replace anticoagulation therapy as the standard of care for patients with AFib.

Since 2016, Inova doctors have successfully performed hundreds of WATCHMAN procedures, and more than 100,000 people worldwide have received a WATCHMAN device to date. Once the device has been implanted and its effectiveness confirmed, doctors can advise their patients on how to stop anticoagulant therapy.

With more size options, the next-generation WATCHMAN FLX™ is designed to work for even more patients with AFib. This newer device, which is FDA approved, also has a frame that makes it easier for doctors to maneuver and implant. Doctors implant the WATCHMAN FLX in the LAA during one minimally invasive procedure, allowing many patients to go home the next day.

AFib Patients Needed for WATCHMAN FLX Trial

Currently, the WATCHMAN FLX is only FDA approved as a stroke prevention device for patients unable to take anticoagulants long term, such as those with high bleeding risk.

Inova and its collaborators in the CHAMPION-AF clinical trial are investigating the efficacy of WATCHMAN FLX to increase access to this treatment for more AFib patients, including those who would otherwise adhere to lifetime anticoagulation therapy.

IHVI doctors are currently recruiting patients for the CHAMPION-AF clinical trial. CHAMPION-AF is a randomized, head-to-head study comparing the WATCHMAN FLX device to traditional anticoagulant therapies, and it includes 3,000 study participants at 150 sites across the world.

Our doctors will closely follow patients throughout the fiveyear study and continue to provide exceptional care for AFib and stroke prevention. A positive outcome from the CHAMPION-AF trial could establish WATCHMAN FLX as the first-line prevention option for patients with AFib.

This trial is another example of Inova’s commitment to providing the latest cardiovascular care. The institution was among the first in the Washington, DC, region to implant the WATCHMAN FLX. As a CHAMPION-AF site, IHVI is among the first in the world to offer this innovative treatment to a broader range of patients.

"At IHVI, our doctors were among the first in the region to offer the WATCHMAN FLXTM device as an alternative to anticoagulant therapy for AFib patients." – Matthew W. Sherwood, MD, MHS, Director, LACC/WATCHMAN Program; Co-Director, IHVI Structural Heart Program; Co-Director, Cardiac Catheterization Laboratories, Inova Fairfax Medical Campus

Learn more about the CHAMPION-AF Trial

Learn More about the Inova Structural Heart/Valve Disease Program

Refer a Patient to the CHAMPION-AF Trial

IHVI is seeking individuals 18 years or older with a nonvalvular AFib diagnosis to participate in the CHAMPION-AF trial. If you have a patient who fits these criteria and is interested in being considered for the trial, email ihviresearch@inova.org or call 703-776-3567.