Cortex announces RESOLVE-AF trial for atrial fibrillation ablation

Cortex revealed today the commencement of its RESOLVE-AF trial (NCT05883631), officially launched in late October 2023. This global, multi-center study aims to clinically evaluate Cortex's Ablamap® System, cleared under 510(k), featuring electrographic flow (EGF) and the newly released Ablacath™ Mapping Catheter basket mapping catheter. The goal is to identify extra-pulmonary vein EGF sources, utilising EGF mapping to individualise ablation strategies based on underlying pathophysiologic mechanisms and potentially enhance outcomes. The trial targets demonstrating that EGF mapping effectively identifies EGF sources beyond pulmonary veins in diverse patients with AFib, including those with paroxysmal, persistent, and long-standing persistent forms, undergoing de novo or redo procedures.

The EGF Mapping system aims to advance patient outcomes by facilitating precise and personalised ablation strategies. AFib, affecting over 30 million patients globally, lacks a consensus on the optimal treatment for persistent cases. Efficient, targeted ablation strategies are particularly crucial when pulmonary vein isolation (PVI) alone is insufficient, a scenario on the rise. Dr. David Haines, Principal Investigator of the RESOLVE-AF study and Director of the Heart Rhythm Center at Corewell Health in Royal Oak, MI, expressed optimism about the Ablamap® System's EGF mapping potential, stating it could be a vital solution for identifying extra-pulmonary vein AF sources. He emphasised that by guiding ablation therapy, EGF mapping enables clinicians to deliver personalised, highly targeted treatment.

The RESOLVE-AF trial, actively enrolling patients at various U.S. centres, has the potential to enrol up to 400 subjects across 20+ centres in the U.S. and Europe. It builds on the recently concluded FLOW-AF trial (NCT04473963), revealing a 51% absolute improvement in freedom from AFib at one year post-ablation for persistent AFib patients using EGF-guided treatment compared to conventional pulmonary vein isolation therapy.

The Ablamap® System, comprising a workstation with software and monitor, amplifier, and proprietary basket mapping catheter and cables, has received positive feedback for its simplicity and insights during complex redo AFib cases, according to Dr. Wilber Su, Director of Cardiac Electrophysiology at Banner-University Medical Center and Associate Professor of Medicine at the University of Arizona.