Study of a Hybrid Approach Using Very High Power Short Duration and AI-Guided Ablation for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation

What this Trial Is About

Researchers are evaluating a new hybrid approach that combines very high power short duration vHPSD and ablation index AI-guided ablation using the QDOT Micro catheter for pulmonary vein isolation PVI in patients with paroxysmal atrial fibrillation PAF. This study aims to investigate whether reducing ablation time with this hybrid method can improve procedural efficiency while maintaining safety and effectiveness. Previous trials suggested that a hybrid approach may balance lesion quality and procedure time, but more data is needed to confirm its benefits. The study involves three experimental groups using different ablation strategies for PVI. One group receives vHPSD ablation only, applying 90 watts for 4 seconds with varying inter-lesion distances depending on the heart segment. Another group receives a combination of vHPSD and AI-guided ablation, with higher power and specific ablation index targets for different areas near the pulmonary veins. The third group receives AI-guided ablation only, with controlled power settings and lesion spacing. If the esophageal temperature rises above 38C near certain segments, a lower power ablation is applied to reduce risk. Participants will be monitored for up to 12 months, with researchers measuring the time taken for AF ablation as the primary outcome. Secondary outcomes include rates of pulmonary vein reconnection, segments with residual potentials, early reconnections, recurrence of atrial fibrillation within a year, and any complications within 30 days after the procedure. The study includes detailed follow-up assessments to evaluate the safety and effectiveness of the ablation strategies over time.

Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation