Patients at Providence Saint John’s Health Center participated in a recently completed global clinical trial to test the safety and effectiveness of a revolutionary device to treat persistent atrial fibrillation, an irregular and often rapid heartbeat known as A-Fib. All the subjects did very well.
Providence Saint John’s was the only hospital in the Western United States to participate in this phase 3 trial of Medtronic’s Sphere-9 to treat A-Fib with an advanced generation of a procedure called ablation that neutralizes the problem area of the heart.
Cardiologist Shephal Doshi, M.D., an electrophysiologist who specializes in ablation therapies and A-Fib, led the trial at the Santa Monica hospital and called the experimental device a “game-changer.”
Currently, ablation involves cauterization on the surface of the heart using a heat or cold source to remove the scarred area, fixing the irregular – and potentially dangerous – heartbeat. Rather than a heat or cold source, the Sphere-9 utilizes pulsed field energy as well as high density mapping to target the affected area of the heart.
“Ablation is a safe and highly effective procedure but there can be complications when you burn or freeze tissue so close to the lungs and the esophagus,” Dr. Doshi said. “This can cause thermal injury. Because of that, it isn’t always recommended for older, more frail patients. The new device would decrease the risk for these patients and allow them to get this important therapy.”
Patients in the trial tolerated the procedure well. One advantage is the new procedure takes much less time compared to two to four hours for standard cauterization.
“The procedure and recovery tend to be quicker,” he said. “Most patients didn’t feel a thing, which is quite impressive.”
It will be at least 18 months before the device is widely available, assuming it is approved by the U.S. Food and Drug Administration, which will review trial data. It is expected to receive European approval soon.
Dr. Doshi described the Sphere-9 device as “a wiffle ball the size of a marble on a stick.” It is inserted into the heart via catheter in a minimally invasive procedure. The tip expands and delivers both radio frequency and pulsed-field energy. It also collects data from the heart to better understand the irregular beat.
Atrial fibrillation is a condition that affects more than 60 million patients globally. Persistent A-Fib occurs when symptoms last for more than seven days and do not correct on their own.
Without early intervention, A-Fib can progress and is associated with a higher rate of cardiovascular hospital admissions, heart failure hospitalization, reduced quality of life and even death. There are three common methods to treat A-Fib – medication, cardioversion or a catheter ablation procedure.
Since the trial began in December 2021, more than 477 patients with persistent A-Fib have been enrolled across 23 centers in the U.S. and Europe. Patients will be assessed for one year for safety and efficacy.
Submitted by Patricia Aidem