The team’s participating in a global clinical trial to assess pulsed field ablation (PFA) technology to treat patients with atrial fibrillation. Developed by Medtronic, the PulseSelect PFA System uses pulsed electric fields to interrupt pathways and atrial fibrillation triggers in the heart. Doing so can help the heart restore its regular rhythm. Unlike traditional methods, this technology is non-thermal (meaning there is no heat or extreme cold) and can efficiently isolate the pulmonary veins, which are a major source of triggers of the arrhythmia.
“This new technology is potentially everything we’ve hoped for in catheter ablation. It’s easier to use, more efficient and will be better for patients because there’s less risk of damage to surrounding tissue and a shorter recovery time. It also may eliminate the need for overnight hospital stays,” said Dr. John Hummel, an electrophysiologist at Ohio State’s Richard M. Ross Heart Hospital, who performed the first procedure on a patient in the United States.
“Whenever you do an ablation, there’s the risk that it can cause damage to structures around the heart as heat or cooling spreads beyond the heart border,” he said. “But this type of energy delivery is nonthermal, and heart muscle cells are uniquely sensitive to it, thus helping to avoid affecting other types of tissue around the heart. It’s also very rapid and will likely significantly cut down on surgery time.”
In January, the U.S. Food and Drug Administration approved the clinical trial, which is funded by Medtronic and for whom Hummel collaborates with as a consultant and researcher. The current phase of the non-randomized study – which also is taking place in Australia, Canada and Europe – is projected to last six months. It’s looking at how effective the PFA system is for patients with recurrent and symptomatic atrial fibrillation and patients who don’t respond to drug therapy.