NCT07156877

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

IsoLation of PuLmonary Vein oUtcome Using a coMbIned Pulse Field Energy and ballooN cAtheTEr in Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Sebastien Knecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether pulsed field ablation (PFA) using the novel VOLT catheter is as safe and effective as conventional thermal ablation (radiofrequency or cryotherapy) for the treatment of atrial fibrillation (AF) in adult patients undergoing their first pulmonary vein isolation (PVI). The main questions it aims to answer are: * Is PFA with the VOLT catheter non-inferior to thermal ablation in preventing recurrence of atrial tachyarrhythmias 2-12 months after the procedure? * Is PFA with the VOLT catheter associated with fewer or comparable serious complications (such as cardiac tamponade, stroke, or phrenic nerve injury)? Researchers will compare the outcomes between patients receiving PFA with the VOLT catheter and those treated with thermal ablation techniques to see if PFA offers comparable or potentially better safety and efficacy. Participants will: * Be randomly assigned (1:1) to receive either pulsed field ablation (PFA) or thermal ablation (radiofrequency or cryotherapy). * Undergo standard follow-up visits at 2-3 months, 6 months, and 12 months post-ablation. * Have repeated ECGs and Holter monitoring to assess heart rhythm. * Complete quality of life questionnaires at baseline, 3, 6, and 12 months. * Use a home ECG device (Kardia Mobile) weekly during the final 3 months of the study. The study includes 136 adults (≥18 years) with paroxysmal or persistent AF, in two participating hospitals. The total study duration is 3 years, including a 2-year enrollment period and 1-year follow-up per participant.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

2 sites across 1 country: Belgium