Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation

NARecruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

January 29, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Atrial Fibrillation (AF)Paroxysmal AF
Interventions
PROCEDURE

PF-only PVI

It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only PF energy for ablation

PROCEDURE

Hybrid PVI

It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing both PF and RF energy for ablation. Specifically, PF energy is used for the posterior segments and RF energy for the anterior segments of the pulmonary veins

PROCEDURE

RF-only PVI

It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only RF energy for ablation

Trial Locations (1)

9300

RECRUITING

OLV Hospital, Aalst

All Listed Sponsors
collaborator

Biosense Webster, Inc.

INDUSTRY

lead

VZW Cardiovascular Research Center Aalst

OTHER