Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation

NANot yet recruitingINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2028

Conditions
Atrial Fibrillation (AF)
Interventions
PROCEDURE

Pulsed Field Ablation (PFA) with VOLT Catheter

Participants in this arm will undergo pulmonary vein isolation (PVI) using the VOLT catheter, a novel single-shot ablation device that delivers pulsed field energy (a non-thermal ablation method). The catheter features a balloon-in-basket design and enables electro-anatomical mapping. The procedure is performed under conscious sedation or general anesthesia and follows standard PVI protocols adapted for the PFA technology.

PROCEDURE

Thermal Ablation (Radiofrequency or Cryoablation)

"Participants in this arm will receive PVI using established thermal ablation techniques, either:~* Radiofrequency ablation, a point-by-point technique using heat delivered through a catheter tip guided by mapping systems, or~* Cryoballoon ablation, which uses freezing energy delivered via a balloon catheter.~The choice between RF and cryoablation is at the discretion of the treating physician, in line with standard care."

Trial Locations (2)

1090

UZ Brussel, Jette

8000

AZ Sint-Jan Brugge AV, Bruges

All Listed Sponsors
lead

Sebastien Knecht

OTHER

NCT07156877 - Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation | Biotech Hunter | Biotech Hunter