The electrophysiology team at Doylestown Health’s AFib Center are among the first in the United States to test a new type of ablation technology for patients suffering from atrial fibrillation.
Electrophysiologists Robert Sangrigoli, MD and John Harding, MD began treating patients in the investigational device exemption (IDE) pivotal trial called PULSED AF. The trial uses the Medtronic PulseSelect™ Pulsed Field Ablation (PFA) System, a breakthrough technology currently being studied to treat atrial fibrillation by interrupting irregular heart rhythms using pulsed electric fields.
Doylestown Health’s medical research program offers patients access to a broad range of clinical trials including heart and vascular studies.
Atrial fibrillation (also called AFib or AF) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. Treatment options include cardiac ablation procedures that target the cause of irregular heart rhythms and destroy the tissue where the faulty electrical signals originate.
The most widely used ablation techniques involve radio frequency (RF) energy that heats the targeted tissue, or balloon ablation with Cryo energy that freezes the targeted tissue. The PulseSelect System delivers pulsed electric fields through an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that trigger atrial fibrillation. However, unlike traditional methods of ablation, the PulseSelect System uses a non-thermal approach and preferentially targets heart tissue with the goal of avoiding unwanted injury to surrounding tissues.
The clinical trial will demonstrate the safety profile of this technology, which has the potential to be a “game changer,” said Dr. Harding.
“While large clinical trials are just now getting underway, early data suggests this technology is safer, more effective and faster than any previous technologies or energy sources in treating AF,” added Dr. Sangrigoli.
PULSED AF is one of two pivotal U.S. trials of pulsed field ablation systems that began in early March. Farapulse is sponsoring the ADVENT randomized trial of the Farapulse PFA system. Doylestown Hospital is one of a few centers in the country enrolling patients in both clinical trials.
“The dedication of our physicians and staff as well as the support from the entire Doylestown Health team allows us to provide not only the highest quality care, but gives us the opportunities to participate in cutting-edge research so that our community of patients can feel confident they are receiving the best care possible,” said Dr. Sangrigoli.