The Herald News FALL RIVER – Southcoast Health is enrolling patients in a new clinical trial to evaluate the use of a new heart ablation technology de
FALL RIVER – Southcoast Health is enrolling patients in a new clinical trial to evaluate the use of a new heart ablation technology designed to treat atrial fibrillation.
The community health system’s Cardiovascular Care Center at Charlton Memorial Hospital was the first in the world to perform the procedure during the pivotal phase of the research trial that precedes FDA approval, said Southcoast Clinical Research Coordinator Debra Benevides.
The investigational device exemption pivotal trial is called Pulsed AF and utilizes the Medtronic PulseSelect Pulsed Field Ablation System, a breakthrough technology that uses pulsed electric fields to treat atrial fibrillation by interrupting irregular heart rhythms.
Atrial fibrillation impacts more than 37 million people worldwide. It’s one of the most common cardiac arrhythmias, in which the upper chambers of the heart or atria quiver or beat very fast and irregularly so the heart cannot effectively pump blood to the body. Treatment options for atrial fibrillation include cardiac ablation procedures that target the cause of irregular heart rhythms.
“Atrial fibrillation is a serious and pervasive condition that can lead to stroke, which is often debilitating and even deadly,” says Dr. Peter Cohn, Physician-in-Chief of the Southcoast Cardiovascular Care Center. “Pulsed AFIB ablation is a groundbreaking technology that we can now offer patients at Charlton Memorial. This clinical trial represents a major advancement in the treatment of this complex disease, and the fact that we are the first to offer this procedure confirms our position as a regional leader in cardiovascular care.”
The PulseSelect System delivers pulsed electric fields through an ablation catheter specifically designed to interrupt irregular electrical pathways in the heart that trigger atrial fibrillation. However, unlike current technology that heat, as with radiofrequency ablation, or cool, as with cryoablation, atrial tissue, the PulseSelect System uses a non-thermal approach and preferentially targets heart tissue intending to avoid unwanted injury to surrounding tissues; a risk of current ablation technologies.
“We are always looking for ways to provide the highest quality of care possible to our patients,” said Dr. Ramin Davoudi, medical director of Electrophysiology at Southcoast Health. “By participating in the Pulsed AF pivotal trial, we are not only providing our clinicians with the opportunity to be part of investigating and using innovative technology, but we also hope to one day to advance patient care for those living with atrial fibrillation.”
Dr. Nitesh Sood, Medical Director of Southcoast’s Atrial Fibrillation Wellness Program, and Dr. Arnoldas Giedrimas, cardiac electrophysiologist, performed the first two PulseSelect Pulsed Field Ablation system procedures. Both procedures were successful, the physicians said.
“Southcoast Health is proud to be on the leading edge of performing this life-changing procedure,” Sood said. “This is a world-class electrophysiology team providing exceptional care close to home, for all communities across southeastern Massachusetts and Rhode Island.”
Charlton Memorial recently became the first hospital in the area to implant the Watchman FLX, another device that addresses atrial fibrillation and is the only center in New England to participate in Boston Scientific’s related Champion AF trial. For more information, visit https://www.southcoast.org/services/cardio-heart-vascular/.
About Southcoast Health
Southcoast Health a not-for-profit, charitable organization and the largest provider of primary and specialty care in the region, serving communities in Rhode Island and across Southeastern Massachusetts.
About PULSED AF
The PULSED AF trial is a prospective, non-randomized, multi-center clinical trial that will enroll up to 500 patients. The treatment includes the PulseSelect System across as many as 50 sites in the U.S., Canada, Europe, and Australia. PULSED AF design evaluates 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. Patients will be assessed at 6 and 12-month intervals.