U.S., Jan. 7 -- ClinicalTrials.gov registry received information related to the study (NCT07320976) titled 'FIH of PFBalloon for PVI' on Dec. 08, 2025.
Brief Summary: The goal of this clinical trial is to assess the safety and effectiveness of a conformal pulsed field ablation (PFA) balloon catheter for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). It will also explore the durable effectiveness of this novel catheter through post-ablation remapping.
The main questions it aims to answer are:
Does the conformal PFA balloon catheter achieve absence of periprocedural primary adverse events (primary safety endpoint)? Does the conformal PFA balloon catheter achieve acute PVI (primary effectiveness endpoin...