58
Participants
Start Date
October 31, 2025
Primary Completion Date
August 31, 2026
Study Completion Date
December 31, 2026
Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT
"FARAWAVE Nav without pre-ablation CT (Intervention Group, n = 29)~Description of the investigation-specific intervention:~Participants in the intervention group will undergo pulmonary vein isolation (PVI) using the second-generation FARAWAVE Nav pulsed field ablation (PFA) catheter without the use of pre-ablation CT imaging. The FARAWAVE Nav catheter integrates magnetic navigation and electroanatomical mapping capabilities, allowing real-time visualization of left atrial anatomy and electrical signals. Energy delivery is based on non-thermal pulsed electric fields (irreversible electroporation), specifically targeting myocardial tissue while sparing surrounding structures."
FARAPULSE with pre-ablation CT
"FARAPULSE with pre-ablation CT (Control Group, n = 29)~Description of the investigation-specific intervention:~Participants in the control group will undergo pulmonary vein isolation (PVI) using the first-generation FARAPULSE pulsed field ablation (PFA) catheter. All patients in this group will undergo pre-procedural cardiac CT imaging to evaluate pulmonary vein anatomy and assist in procedural planning. The FARAPULSE catheter delivers non-thermal pulsed electric fields for selective myocardial ablation, aiming to achieve electrical isolation of the pulmonary veins."
Cardiocentro Ticino
OTHER