Beaumont Health System in Royal Oak is the first center outside of Japan to begin testing a new treatment for a heart rhythm disorder that affects about 3 million people in the United States.
The treatment, which is not yet approved by the U.S. Food and Drug Administration, uses a special catheter equipped with a balloon that is inflated with liquid then heated to burn or remove tissue that triggers impulses that cause atrial fibrillation.
“This treatment is designed for people with paroxysmal atrial fibrillation — a rapid, irregular heart rhythm that comes and goes on its own and has not responded to anti-arrythmic drugs,” says Dr. David Haines, director of Beaumont’s Heart Rhythm Center.
Haines will lead the national research study in testing the safety and effectiveness of the device. A total of 35 patients will take part in the study at five centers in the U.S. In Japan, nearly 500 people have participated in studies using the device.
“We are hopeful that this procedure will be safer, faster, and as effective as current approved technologies for atrial fibrillation ablation,” Haines says.
People with atrial fibrillation have an irregular heartbeat that is sometimes too fast and causes symptoms like feelings of weakness, dizziness, or lightheadedness, and/or an uncomfortable racing or unusual heartbeat. The condition puts them at increased risk of a stroke.