Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters

NANot yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2026

Conditions
Atrial Fibrillation (AF)Atrial Fibrillation AblationPulsed Field Ablation
Interventions
DEVICE

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."

DEVICE

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."

All Listed Sponsors
lead

Cardiocentro Ticino

OTHER

NCT07130773 - Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters | Biotech Hunter | Biotech Hunter