Evaluation of the CoreMap Electrophysiology Mapping System for Treating Persistent and Long-Standing Persistent Atrial Fibrillation

What this Trial Is About

This research evaluates the CoreMap Electrophysiology EP Mapping System in patients with persistent atrial fibrillation PerAF and long-standing persistent atrial fibrillation. The study is conducted in three phases to assess the safety and effectiveness of this device-guided approach for mapping heart activity and guiding ablation treatment. The trial aims to improve identification and treatment of AF drivers, particularly in patients without prior ablation therapy. The study uses the CoreMap EP Mapping System for endocardial mapping to collect detailed heart electrical signals in Phase 1. Phase 2 focuses on developing and evaluating a tailored ablation strategy guided by this mapping system. Phase 3 compares the mapping-guided ablation to a control group to assess safety and effectiveness in patients with no prior AF ablation. Each phase has specific goals related to safety and treatment response. Participants undergo high-fidelity electrogram collection and ablation procedures as per their assigned study phase. Evaluations include safety monitoring perioperatively and at follow-up times of 7 days, 6 months, and 12 months depending on the phase. Patients provide informed consent and are monitored through study procedures designed to assess heart function and treatment outcomes until study completion in 2026.

Endocardial Mapping With the CoreMap EP Mapping System