Community Healthcare System is pleased to announce its participation in a clinical trial comparing the safety and efficacy of the WATCHMAN FLX™ left atrial appendage closure (LAAC) device against contemporary blood thinners.
The WATCHMAN FLX device replaces long-term blood thinner use by closing the left atrial appendage to reduce stroke risk in patients with atrial fibrillation (A-Fib) not caused by a heart valve issue. The CHAMPION-AF Clinical Trial is studying WATCHMAN FLX as an option to replace blood thinners for patients with non-valvular A-Fib who are not able to tolerate long-term blood thinner use, but would consider a one-time, device option for stroke risk reduction.
“Our cardiovascular teams were the first in Northwest Indiana to offer WATCHMAN and the next-generation WATCHMAN FLX as an effective treatment option for these patients,” said Samer Abbas, MD, medical director of Cardiovascular Services at Community Hospital and the Structural Heart program of Community Healthcare System. “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.”
The CHAMPION-AF trial includes patients at low to moderate risk of bleeding from the use of blood thinners, or those who are simply seeking an alternative to long-term anticoagulation.
“Community Healthcare System has a well-established history of providing excellence and innovation in cardiac care which has distinguished us as a leading site for clinical trials such as this,” added Abbas. “We are fortunate to have been asked to participate in this study in the company of nationally-recognized centers such as Mayo Clinic, Cleveland Clinic and others.”
Who is eligible for the CHAMPION-AF trial?
Patients who decide to participate in the study will agree, by random selection, to receive either 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 adverse events over five years. Approximately 20 patients will be enrolled in clinical trial at Community Healthcare System. Worldwide, the trial will study 3,000 patients at approximately 150 sites.
David Orchowski, a 71-year-old resident of Chicago’s Hegewisch neighborhood, was the first patient at Community Healthcare System to enroll in the study. In October, he underwent a 45-minute procedure to have the WATCHMAN FLX device inserted. “It could be one more tool in the toolbox that doctors have available to them to help people live a longer, healthier life with less fear of a stroke.” Participating in the program is not complicated, Orchowski explained. He occasionally answers questions over the phone about his health and meets regularly with his doctor. “I am extremely pleased with how things are going,” he said. “I look forward to being a participant over the long haul.”
“A positive outcome from the CHAMPION-AF trial may put the WATCHMAN FLX 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 life-long use of blood thinners and the associated risk of serious bleeding,” Abbas said. “Our participation in important studies such as this ensures we maintain that level of excellence and contribute to a broader knowledge through cardiovascular research.”
The CHAMPION-AF clinical trial is part of the Cardiovascular Research program at Community Healthcare System. The Cardiovascular Research program is dedicated toward improving the heart health of the community through education and the advancement of knowledge from clinical trials. These initiatives have made it possible for the system's hospitals to participate in national trials directed at better detection, treatments and the prevention of heart disease.
Potential patients for the CHAMPION-AF clinical trial should call (219) 703-1152 to schedule an appointment.
For more information about cardiovascular research and heart care at the hospitals of Community Healthcare System: Community Hospital in Munster, St. Catherine Hospital in East Chicago, St. Mary Medical Center in Hobart and Community Stroke & Rehabilitation Center in Crown Point, visit COMHS.org/heart.