Billings Clinic participating in a clinical trial for an alternative treatment to long term blood thinners in patients with atrial fibrillation
Billings Clinic is participating in a national trial to study the use of an advanced device to treat patients with atrial fibrillation who are at higher risk for stroke and we are enrolling participants now.
Called the CHAMPION-AF trial and initiated by Boston Scientific, it is a randomized head-to-head trial designed to evaluate the safety and efficacy of the next-generation WATCHMAN FLX Left Atrial Appendage Closure Device within a broad population of patients with non-valvular atrial fibrillation (AF), including those who are at low-to-moderate risk of bleeding from the use of blood thinners. The device will be compared to results from leading contemporary blood thinner medications for stroke risk reduction in this population and provide a procedural option for those who may not otherwise qualify for the WATCHMAN device.
Billings Clinic has been a leader in providing the WATCHMAN procedure.
“Being selected to participate in this trial allows us to be the only health care system in a multistate area to offer this next generation WATCHMAN device. It really reaffirms our standing as a national leader in cardiovascular care.” said Dr. Brian Rah, Department Chair of Cardiology.
It is a minimally invasive procedure that is implanted like a stent, by means of a narrow tube inserted through a small incision in the upper leg. The procedure is done under general anesthesia and takes about an hour.
Approximately 33 million people worldwide have AF, a common heart rhythm disorder, which makes them five times more likely to have a stroke than someone with a normal heart rhythm. In patients with non-valvular atrial fibrillation, more than 90% of heart-related blood clots form in the left atrial appendage. The WATCHMAN device is designed to close off this area of the heart permanently, providing a one-time solution for those who need an alternative treatment to reduce their risk of stroke.
The trial will study 3,000 patients suitable for oral anticoagulation across a broad spectrum of bleeding risk. Patients at approximately 150 global sites will be randomized to receive either the WATCHMAN device or a drug treatment and be evaluated for rates of stroke, bleeding and other major adverse events over five years.
“We are pleased to participate in this important study that will evaluate whether a one-time WATCHMAN FLX procedure is as effective as blood thinning medication as a first-line treatment for a wider population of patients,” said Dr. Loren Budge, principal investigator and medical director of electrophysiology at Billings Clinic. “A positive outcome from the CHAMPION-AF trial may put this device on equal footing with best-in-class drug therapy for stroke risk reduction while offering an alternative for more patients who would otherwise face life-long use of blood thinners and the associated risk of serious bleeding.”
CHAMPION-AF may be appropriate for patients who have been diagnosed with AF, not caused by a heart valve problem, and have been deemed suitable for long term blood thinner therapy.
For more information WATCHMAN and the CHAMPION-AF trial, please call Tanja Sloan, PA-C, Billings Clinic WATCHMAN Coordinator, at 406-238-2004 or visit www.billingsclinic.com/watchman.