Comparing New and Standard Pulmonary Vein Isolation Catheters for Treating Atrial Fibrillation Without Pre-Ablation CT Scans

What this Trial Is About

Researchers are evaluating the use of two different pulsed field ablation PFA catheters for treating atrial fibrillation AF, a heart rhythm disorder. The first-generation FARAPULSE catheter requires pre-procedural CT imaging to guide the procedure, which adds costs, radiation exposure, and logistical challenges. The second-generation FARAWAVE Nav catheter combines magnetic navigation, detailed mapping, and PFA therapy in one device, potentially improving precision and reducing the need for CT imaging. Participants will be randomly assigned to one of two groups one using the FARAPULSE catheter with pre-ablation CT imaging, and the other using the FARAWAVE Nav catheter without CT. The FARAWAVE Nav catheter uses advanced mapping software to visualize heart anatomy and electrical activity during the procedure, aiming to isolate the pulmonary veins that contribute to AF. The study will compare fluoroscopy time, radiation exposure, procedural time, costs, number of PFA applications, and AF recurrence between the two groups. During the study, participants will undergo pulmonary vein isolation using the assigned catheter. Researchers will collect data on fluoroscopy time immediately after the procedure and track radiation dose, procedure duration, and AF recurrence for up to six months. The study includes detailed monitoring of heart activity and procedural effectiveness. Total participation includes the procedure and follow-up evaluations to assess outcomes and safety.

Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters