Inova Heart and Vascular Institute Recruiting Patients for AFib Stroke Prevention Device Clinical Trial

Matthew W. Sherwood, MD, MHS, is an Inova interventional cardiologist, Director of Inova’s Left Atrial Appendage Closure/WATCHMAN Program and Co-Director of Inova’s Structural Heart Disease Program. Dr. Sherwood is board-certified in interventional cardiology, cardiovascular disease and internal medicine.

Millions of Americans have atrial fibrillation (AFib) and take oral anticoagulant medication (blood thinners) every day. These medications can reduce the risk of a stroke, which is more common if you have AFib. But blood thinners come with side effects like bleeding, bruising and the expense of daily prescription medication.

Doctors at the Inova Heart and Vascular Institute (IHVI) believe there’s a better solution for many people with AFib. That’s why we’re participating in a global clinical trial to compare a leading-edge heart implant device to blood thinners. The results of this study could mean that more people with AFib might be able to discontinue blood thinners for good.

The Stroke and AFib Connection

AFib is an abnormal heart rhythm that causes heartbeats that are too slow, too fast or irregular. The heart’s erratic rhythm causes blood flow to slow down. When blood flows slowly, it has time to pool and form a clot. A stroke happens when a clot forms and travels to the brain.

People with AFib are five times more likely to have a stroke than people without the condition. And more than 90 percent of AFib strokes form in a small pocket in the heart called the left atrial appendage (LAA).

Reducing Stroke Risk Without Blood Thinners

IHVI doctors were among the first in the region to offer the WATCHMAN™ device to people with AFib. WATCHMAN is an FDA-approved device that seals off the LAA, preventing blood clots and strokes. This implantable device was specially designed to be a blood thinner alternative for people with AFib.

Since 2016, Inova doctors have successfully performed hundreds of WATCHMAN procedures. And more than 100,000 people across the world have received a WATCHMAN device to date. People who have these implants work with their doctors to stop taking blood thinners once the device’s effectiveness is confirmed.

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

AFib Patients Needed for WATCHMAN FLX Trial

Currently, the WATCHMAN FLX is approved as a stroke prevention device for patients who cannot take blood thinners on a long-term basis. But Inova is taking part in a groundbreaking clinical trial that could make the WATCHMAN FLX available to more people. This includes people who would likely otherwise take blood thinners for life.

IHVI doctors are recruiting patients for the CHAMPION-AF clinical trial beginning in summer 2021. This is a randomized, head-to-head trial that will compare the WATCHMAN FLX device to the latest blood thinners. The trial will include 3,000 people at 150 sites across the world. Throughout the five-year study, our doctors will closely follow patients and continue to provide exceptional care for AFib and stroke prevention.

A positive outcome from the CHAMPION-AF trial could change the way we prevent strokes in many people with AFib. Good results may show that the WATCHMAN FLX works well as a first-line stroke prevention option. In fact, even people who don’t have high bleeding risk could choose WATCHMAN FLX as an alternative to blood thinners.  

This trial is another example of Inova’s commitment to providing the latest cardiovascular care. We were among the first in the Washington, D.C., region to implant the WATCHMAN FLX. As a CHAMPION-AF site, we are among the first in the world to offer this innovative treatment to a wider range of people. Learn more about Inova’s atrial fibrillation program.

How to Enroll in the CHAMPION-AF Trial

To participate in the CHAMPION-AF trial, you must be 18 years or older and have a diagnosis of non-valvular atrial fibrillation. Participants will also meet other criteria that you can discuss with your cardiologist. If you’re interested in being considered for the trial, contact:

• IHVIResearch@inova.org
•  703-776-3567