Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF

NANot yet recruitingINTERVENTIONAL
Enrollment

298

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

July 31, 2029

Study Completion Date

July 31, 2029

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

CT myocardial thickness map guided PV isolation group

Pulmonary vein isolation will be performed using the PulseSelect™ pulsed field ablation system. A pre-procedural cardiac CT scan will be used to generate an atrial myocardial thickness map. In this group, atrial segments with wall thickness \>2.5 mm identified on the CT map will receive additional PFA applications (up to 8 per PV) to ensure transmural lesion formation. All other segments will receive the standard minimum of 8 applications per vein. The ablation catheter will remain stationary to allow lesion stacking when needed.

PROCEDURE

Empirical PV isolation group

Pulmonary vein isolation will be performed using the PulseSelect™ pulsed field ablation system according to a standardized empirical protocol. Each pulmonary vein will receive a minimum of 8 PFA applications without adjustment based on anatomical or CT-based parameters. Additional applications may be delivered at the operator's discretion based on procedural findings, but no wall thickness mapping will be used.

Trial Locations (1)

120-752

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT07068646 - Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF | Biotech Hunter | Biotech Hunter