The FDA has approved a Medtronic-run trial, PULSED AF, to evaluate the safety and efficacy of new tech that uses pulsed electric fields to treat AFib.
The study will be an investigational device exemption (IDE) trial, according to Medtronic, since the company’s PulseSelect Pulsed Field Ablation (PFA) System isn’t yet approved for sale or distribution. PFA was granted breakthrough designation by the FDA in September of 2018 for the treatment of drug-refractory recurrent symptomatic atrial fibrillation.
PFA uses pulsed electric fields to ablate or create lesions and scar tissue to interrupt electrical pathways and AFib triggers in the heart, and unlike other traditional methods of ablation, it’s non-thermal and selectively targets cardiomyocytes while avoiding other types of tissue.
“This study will evaluate a new energy source that may treat atrial fibrillation and potentially address the risks that have been associated with other ablation technologies, such as unintended tissue damage,” Atul Verma, MD, principal investigator for PULSED AF, said in a statement. “The rigorous pre-clinical research to get us to these first procedures has been impressive and we are excited to support the development of more clinical evidence.”
PULSED AF is a prospective, non-randomized, unblinded study that will enroll patients to be treated with the PulseSelect PFA System. First procedures were performed in December 2019 and January 2020.