FARAPULSE has announced that the first patients have been treated in the ADVENT trial, a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its pulsed field ablation (PFA) system for the treatment of paroxysmal atrial fibrillation (AF).
The ADVENT trial is a randomised controlled trial that will involve at least 350 patients in over 30 US centres. Patients will be randomised in a 1:1 fashion to either FARAPULSE PFA or standard ablation, using radiofrequency or cryoballoon ablation. The primary endpoint will be freedom from AF for 12 months after a single ablation procedure.
The first patients were treated at Mount Sinai Hospital (New York, USA) by Vivek Reddy, the Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai and the trial’s principal investigator.
“The ADVENT trial is uniquely positioned to change our field: it is not only the first pivotal trial of PFA but also the only randomised one approved to commence by the FDA. I fully expect that when complete, this trial will provide definitive evidence for a change in how electrophysiologists treat patients with AF,” said Reddy. “Mount Sinai Heart fosters innovation in medicine, evidenced by our first enrolments in this landmark clinical study.”
“On the basis of our preclinical and clinical data beginning in 2013, FARAPULSE PFA represents a generational breakthrough in the treatment of AF,” said Allan Zingeler, president and CEO of FARAPULSE. “We believe PFA will simplify the ablation procedure for physicians and increase its safety margin by practically eliminating many of the procedural risks associated with today’s standard of care. We are eager to prove this in the ADVENT trial, which will be conducted by more than 50 leading electrophysiologists across the USA.”
Ablation is a non-surgical procedure used to correct certain heart rhythm abnormalities such as AF. During an ablation procedure, a thin, flexible tube called a catheter is guided to the interior of the heart from the patient’s groin. Traditionally, the tip of an ablation catheter generates extreme temperatures—hot or cold—to eliminate the targeted heart tissue associated with irregular heartbeats. The PFA system, however, relies on non-thermal electric fields that are tissue-selective.
More than 170 patients have been treated with the FARAPULSE PFA system in European feasibility studies.