Ranked the eighth best hospital in Pennsylvania, Doylestown Health also conducts clinical trials as part of a comprehensive research program, offering patients access to advanced treatments, including heart and vascular studies. With the research as a care option progressing, this borough in Bucks County north of Philadelphia now offers what one doctor here calls a “revolutionary” innovative breakthrough deemed “…the next big step in cardiac ablation.” Sponsors should be aware of the capabilities of Doylestown and the trial site’s ability to run actually two major, high-volume clinical trials involving pulsed field ablation systems for atrial fibrillation.
Atrial fibrillation (AFib or AF), that quivering or irregular heartbeat known as arrhythmia, reports Buck’s Local News, can lead to real problems, from blood clots and stroke to heart failure or other cardiovascular-related conditions and complications. The most common type of treated heart arrhythmia, about 2.7 million Americans live with AF. Current treatments include cardiac ablation procedures, ones that target the cause of the irregular heart rhythms, destroying the delicate tissue where the faulty electrical signals originate, reports the Advance of Bucks County.
Current Standard of Care
Today, the most widely used approach to treat this condition is known as ablation techniques, which involve radio frequency (RF) energy that actually heats the targeted tissue (balloon ablation) with Cryo energy that freezes the targeted tissue. Robert Sangrigoli, MD, an electrophysiologist here, recently shared for the local press, “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 the targeted site.”
The PULSED AF Trial
Doylestown Health serves as a trial site location for the investigational device exemption (IDE) pivotal trial known as PULSED AF. The 500 participant prospective, multi-center, non-randomized, unblinded worldwide premarket clinical study (NCT04198701) serves to generate data demonstrating the effectiveness of the PulseSelect™ PFSA System for the treatment of AF. The clinical trial started at the end of 2019 and runs through till October 2022.
This study also serves to generate insights into clinical safety and device function for the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. Divided into stages, this study involves a pilot and pivotal phase, with each one comprising discreet data sets that will be analyzed and reported on. Sponsored by Medtronic here at Doylestown Health, Dr. Sangrigoli serves as Principal Investigator along with the support of Dr. John Harding.
This new technology delivers pulsed electric fields via an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that can lead to AF. This study tests the safety and efficacy of the investigational product on the treatment of A in adult patients with a history of drug refractory, recurrent, and symptomatic paroxysmal or persistent AF.
Breakthrough Technology Comes to Bucks County
This news investigational technology isn’t like the traditional methods of ablation that heat via radiofrequency ablation or cooling via cryoablation the atrial tissue reports the local news. Rather, this novel technology from Medtronic uses a non-thermal method, targeting heart tissue with an aim of avoiding any unwanted injury to the adjacent tissues, such as the esophagus, aorta, lungs and the phrenic nerve which is important for breathing.
Dr. Sangrigoli reports that “Pulsed field ablation (PFA) is very different from current ablation techniques.” He continued “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.”
Dr. Harding even goes a step further, declaring that this clinical trial represents a potential “game changer.” Of course, the proof must be in the data, and the study is just underway, but Sangrigoli suggests, “early data suggests this technology is safer, more effective and faster than any previous technologies or energy sources in treating AF.”
Multiple Studies at the Trial Site
There are actually two pivotal clinical trials in America investigating pulsed field ablation systems, including 1) PULSED AF and 2) Farapulse PFA system.
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. Doylestown Hospital is one of a few centers in the country enrolling patients in both clinical trials reports Advance of Bucks County.
As discussed in the local press, Doylestown Health’s clinical research group dedicates its mission to the quality of life for members of the community by introducing and engaging in research, offering access to the latest technology and drug therapies. The hospital conducts a number of research programs.
Call to Action: For those in Bucks County that are interested in this study, contact Linda Schwarz, BSN, CRC, at 215-933-0053. For general information about research opportunities at Doylestown, call their main number at 215-345-2119.