Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal...

Background: Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI.

Methods And Results: The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.

Conclusions: This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.

Trial Registration: https://www.

Clinicaltrials: gov/study/NCT06014996; NCT06014996.