Clinical trial at Advocate Aurora in Milwaukee aims to improve standard of care for AFib patients
MILWAUKEE, Wis. (CBS 58)-- The Advocate Aurora Research Institute is conducting a clinical trial in Milwaukee that could improve the standard of care for nearly three million Americans.
Wayne Christiansen is one of those people. He was diagnosed with atrial fibrillation (AFib) 20 years ago.
AFib can cause blood clots to form in the left atrial appendage, which can lead to a stroke.
Doctors tried to treat the irregular heart rhythm with blood thinners, which only turned into countless emergency room visits anytime Christiansen had a bloody nose or cut.
"You'd just never stop the bleeding," Christiansen said. "I had so much difficulty with the blood thinners. I was desperate to try anything."
New hope surfaced with the WATCHMAN FLX device. It plugs the left atrial appendage, replacing the need for blood thinners altogether.
The problem for Christiansen: it's only approved for high risk patients.
"I was really close, but even with all of my bleeding, I still don't qualify," Christiansen said.
The CHAMPION-AF clinical trial, conducted at the Advocate Aurora Research Institute, could make it possible for more AFib patients to get the device.
"Our patients that are in the CHAMPION study for instance, have the opportunity of being able to get the WATCHMAN device in a situation they would not have had that capability before," Clinical Research Coordinator at the Advocate Aurora Research Institute, Anthony Chambers said.
The study is aiming to prove that the device works just as well, if not better, than blood thinners. Participating patients are randomly chosen to get the device or stay in the control group.
Christiansen received the device four months ago.
The principal investigator calls it a game-changer, significantly lowering the risk of stroke in AFib patients.
"You can put it in a patient with a two hour procedure, and then they don't have to take a blood thinner for the rest of their life," Dr. Jasbir Sra said.
Christiansen said he is already noticing the improvement in his quality of life.
"If I cut myself, I don't have to make a big deal out of it," Christiansen said.
The trial aims to enroll 3,000 patients with AFib. Patients will need to follow up with researchers for five years.