Doylestown Health Participates in Groundbreaking Clinical Trials

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 treated three patients on March 15 and 16 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.

“We are thrilled to have the opportunity to offer this to our patients and thrilled to participate in groundbreaking clinical trials evaluating PFA,” said Dr. Sangrigoli.

Calling the innovative technology “revolutionary,” Dr. Harding added, “This is the next big step in cardiac ablation.”

Doylestown Health’s medical research program offers patients access to a broad range of clinical trials including heart and vascular studies. Clinical trials test new and innovative treatments and therapies, a critical part of advancing medicine.

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. AF is the most common type of treated heart arrhythmia. At least 2.7 million Americans are living with AF. 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. “While successful, RF energy and Cryo energy are not perfect and may occasionally result in incomplete elimination of the targeted tissue and rarely inadvertent damage of tissue beyond the target related to ‘thermal creep’ from heating or freezing at the target site,” explained Dr. Sangrigoli.

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 that heat (radiofrequency ablation) or cool (cryoablation) the atrial tissue, the PulseSelect System uses a non-thermal approach and preferentially targets heart tissue with the goal of avoiding unwanted injury to surrounding tissues, including the esophagus, aorta, lungs and phrenic nerve (important for breathing).

“Pulsed field ablation (PFA) is very different from current ablation techniques,” noted Dr. Sangrigoli. “PFA delivers very short duration (nanoseconds to milliseconds) energy pulses, which is very effective at eliminating only the targeted tissue with essentially no change in temperature, thereby protecting nearby tissue.”

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.

The PULSED AF trial is a prospective, non-randomized, multi-center clinical trial that will enroll up to 500 patients who will be treated with the PulseSelect System across as many as 50 sites in the U.S., Canada, Europe, and Australia. PULSED AF is designed to evaluate the safety and efficacy of the PulseSelect System for the treatment of AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF.

Doylestown Health’s AFib Center is a high-volume center in the treatment of heart arrhythmia conditions, with success rates comparable to the leading AFib centers across the United States.

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.

The Mission of Clinical Research at Doylestown Health is to improve the quality of life for the members of the community by engaging in research, which will provide increased access to the latest technology and advanced drug therapies. If you would like to learn more about this particular study, please call Linda Schwarz, BSN CRC at 215-933-0053. If you wish to gather general information about research opportunities at Doylestown, please call our main number at 215-345-2119.