Safety and chronic lesion characterization of pulsed field ablation in a Porcine model.

Mark T StewartDavid E HainesDamijan MiklavčičBor KosNicole KirchhofNoah BarkaLars MattisonMatt MartienBirce OnalBrian HowardAtul Verma

Published in: Journal of cardiovascular electrophysiology (2021)

PFA deliveries to the SVC, RAA, and RSPV resulted in complete circumferential replacement fibrosis at 4-week postablation with an excellent chronic myocardial and collateral tissue safety profile. This GLP study evaluated the safety and efficacy of a dosage range in preparation for a clinical trial and characterized the non-thermal nature of PFA.

Keyphrases

clinical trial
randomized controlled trial
study protocol
mass spectrometry
open label
high resolution
simultaneous determination