Patients at low to moderate risk of bleeding from the use of blood thinners can be included in the trial.
A new clinical trial, known as CHAMPION-AF, is underway to evaluate the safety and efficacy of the next-generation WATCHMAN FLX left atrial appendage closure (LAAC) device compared with a new generation of blood thinners within a broad population of patients with nonvalvular atrial fibrillation (A-fib).
The WATCHMAN FLX device replaces long-term blood thinner use by closing the left atrial appendage, where 90% of the strokes from A-fib originate.
Patients in the CHAMPION-AF trial, by random selection, either will receive the WATCHMAN FLX device or continue on oral anticoagulation medication to address their stroke risk. The patients will be evaluated for rates of stroke, bleeding and other major adverse events over five years.
Norton Heart & Vascular Institute Heart Rhythm Center is Kentucky’s only participant in the CHAMPION-AF clinical trial.
Refer a patient
If you have a patient who may be eligible for the Champion trial, contact Norton Heart & Vascular Institute.
Norton Heart & Vascular Institute has been performing WATCHMAN implants since 2016 and has more experience with this treatment than any other hospital system in Louisville or Southern Indiana.
“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 nonvalvular A-fib,” said Tara U. Mudd, APRN, nurse practitioner with
Who Is eligible for the CHAMPION-AF trial?
The CHAMPION-AF trial will include patients at low to moderate risk of bleeding from the use of blood thinners, or those who are simply seeking out an alternative to long-term anticoagulation.
“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 and offer an alternative for more patients who would otherwise face lifelong use of blood thinners and the associated risk of serious bleeding,” said Kent E. Morris, electrophysiologist and associate director of cardiology with Norton Heart & Vascular Institute.