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

NCT07156877 | Recruiting

• 1 other identifier: ILLUMINATE-AF
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Atrial fibrillation; Pulmonary vein isolation; Pulsed field ablation

Outcome Measures

Primary Outcomes (3)

• Time to first recurrence of any atrial tachyarrhythmia

  The primary endpoint is the time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) after 12 months following the ablation procedure, as detected on repetitive Holter and home monitoring. During the first 2 months after the procedure (blanking period), recurrent AF or atrial tachycardia will be treated with antiarrhythmic drugs or cardioversion as needed, and won't be considered treatment failure. Atrial tachyarrhythmia recurrence is defined as continuous arrhythmia lasting 30 seconds or longer. Potential arrhythmia events will be independently reviewed and adjudicated by a clinical events committee comprised of 3 experienced electrophysiologists who are blinded to treatment allocation.

  Between 2 and 12 months post ablation

• Number of safety events, composite of cardiac tamponade, phrenic nerve palsy, vascular complications, stroke/transient ischemic attack, atrio-esophageal fistula and death

  The primary safety endpoint is a composite of: 1. Cardiac tamponade requiring pericardiocentesis 2. Persistent phrenic nerve palsy lasting more than 24 hours 3. Serious vascular complications requiring intervention 4. Stroke/transient ischemic attack 5. Atrio-esophageal fistula 6. Death The safety endpoint is assessed during catheter ablation, until discharge, and during the following 30 days. Information on safety events are collected throughout the trial by the investigators or their designees. All primary safety events will be reviewed and adjudicated by the clinical events committee members.

  From ablation until 30 days post ablation

• Procedure duration (minutes)

  Total procedure duration (minutes)

  Day of ablation procedure

Secondary Outcomes (7)

• Left atrial dwelling time (minutes)

  Day of ablation procedure

• Fluoroscopy time (minutes)

  Day of ablation procedure

• AF burden: percentage of time in AF on 7 day Holter (%)

  Before ablation, and 6 months and 12 months post ablation

• Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%)

  From ablation until 12 months post ablation

• Proportion of patients undergoing a repeat ablation (%)

  From ablation until 12 months post ablation

Study Arms (2)

Pulsed Field Ablation (PFA) Arm - VOLT Catheter

EXPERIMENTAL

Participants randomized to this group will undergo pulmonary vein isolation using the novel VOLT catheter, which delivers non-thermal pulsed field energy to ablate heart tissue. The VOLT catheter features a balloon-in-basket design and is compatible with electro-anatomical mapping systems. This technique aims to selectively target heart tissue while minimizing damage to surrounding structures.

Procedure: Pulsed Field Ablation (PFA) with VOLT Catheter

Thermal Ablation Arm - Radiofrequency or Cryoablation

ACTIVE COMPARATOR

Participants in this group will receive conventional thermal ablation, either using radiofrequency energy (point-by-point ablation guided by mapping) or cryoballoon ablation (freezing tissue using a balloon catheter). These techniques create scar tissue to block abnormal electrical signals causing atrial fibrillation.

Procedure: Thermal Ablation (Radiofrequency or Cryoablation)

Interventions

Pulsed Field Ablation (PFA) with VOLT Catheter PROCEDURE

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.

Pulsed Field Ablation (PFA) Arm - VOLT Catheter

Thermal Ablation (Radiofrequency or Cryoablation) PROCEDURE

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.

Thermal Ablation Arm - Radiofrequency or Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal or persistent atrial fibrillation documented on a 12 lead electrocardiogram or Holter monitor (lasting ≥30 seconds) within the last 24 months.
• Candidate for ablation based on current AF guidelines
• Continuous anticoagulation with Vitamin-K-Antagonists or a non-vitamin K antagonist anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a transesophageal echocardiogram (TEE) and/or computed tomography (CT) that excludes left atrial thrombus ≤48 hours before ablation
• Age of 18 years or older on the date of consent
• Informed consent as documented by signature

You may not qualify if:

• History of left atrial (LA) ablation or surgery involving the LA
• Persistent atrial fibrillation (AF) lasting longer than 12 months
• AF resulting from temporary or reversible causes
• Presence of thrombus within the heart chambers
• Prior pulmonary vein (PV) stenosis or stenting
• Existing paralysis of one side of the diaphragm
• Known allergy or contraindication to anticoagulant medication or contrast agents
• History of mitral valve surgery
• Significant mitral valve disease
• Myocardial infarction occurring within three months prior to informed consent
• Current use of triple antithrombotic therapy
• Cardiac surgery within the past three months or a scheduled cardiac surgery or TAVI
• Major congenital heart abnormalities
• Congestive heart failure classified as NYHA class III or IV
• Left ventricular ejection fraction (LVEF) less than 35%

Sponsors & Collaborators

• Sebastien Knecht: lead

Study Sites (2)

AZ Sint-Jan Brugge AV

Bruges, 8000, Belgium

RECRUITING

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Desmoglein 1; Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Sébastien Knecht, MD, PhD

  AZ Sint-Jan Brugge AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Christiaen, PhD

CONTACT

+32 50453293; emma.christiaen@azsintjan.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 5, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)