MANIFEST-US Multicenter Registry on Pulsed Field Ablation

This document is a technical report detailing the findings from the MANIFEST-US Multicenter Registry, which evaluated the safety and real-world use of the FARAPULSE™ Pulsed Field Ablation System in over 41,000 patients across the United States. The study was designed as a retrospective observational analysis, collecting data from 102 centers and more than 500 operators. The report outlines the demographics, procedural details, and adverse events associated with the use of the FARAPULSE system from February 2024 to July 2025. The major adverse event rate was noted to be 0.63%, with vascular access complications being the most common. The report also discusses the low rates of severe complications, including no reports of esophageal fistula or persistent phrenic nerve injury. The findings reinforce the favorable safety profile of the FARAPULSE system, establishing a benchmark for future studies and post-approval surveillance.