Franciscan Health Indianapolis Clinical Trial Tests Effectiveness Of New Device

INDIANAPOLIS, Indiana - Franciscan Health Indianapolis is participating in a clinical trial testing a device that reduces the risk of stroke for atrial fibrillation (AFib) patients compared to the use of 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 WATCMAN 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 (NOACs), 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 Saeed R. Shaikh, MD, MBA, and principal investigator of the study and a member of Franciscan Physician Network Indiana Heart Physicians. "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 life-long use of blood thinners and the associated risk of serious bleeding."

Franciscan Health Indianapolis was the first site in Indiana to offer this opportunity.

The trial will study 3,000 patients suitable for oral anticoagulation across a broad spectrum of bleeding risk. Patients at approximately 150 global sites, including Franciscan, 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.

The CHAMPION-AF clinical trial aims to expand WATCHMAN as a first-choice option versus blood thinners to more AFib patients and is open to any non-valvular AFib (NVAF) patient who is at increased risk for stroke and SE based on their CHADS2-VASc score and able to tolerate long term OAC. 

Patients receiving the WATCHMAN FLX device undergo a one-time minimally invasive procedure that lasts an average of 60 minutes under anesthesia. The device is inserted through a catheter in the groin area. It is then implanted in the heart to close off the LAA, the most common site where harmful blood clots form in patients with AFib. The small device then prevents clots from entering the bloodstream, where they might otherwise travel to the brain, causing a stroke.

For more information about Franciscan Health's cardiac and vascular services, go to FranciscanHealth.org. To learn more about Boston Scientific and the CHAMPION-AF trial, visit BostonScientific.com.