MedTrace Logo

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

NCT07156877 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-05-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sebastien Knecht

    lead OTHER

Principal Investigators

  • Sébastien Knecht, MD, PhD · AZ Sint-Jan Brugge AV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156877 on ClinicalTrials.gov