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

NCT ID: NCT07156877

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-11-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulsed Field Ablation (PFA) Arm - VOLT Catheter

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.

Group Type: EXPERIMENTAL

Pulsed Field Ablation (PFA) with VOLT Catheter

Intervention Type: 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.

Thermal Ablation Arm - Radiofrequency or Cryoablation

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.

Group Type: ACTIVE_COMPARATOR

Thermal Ablation (Radiofrequency or Cryoablation)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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%
• Diagnosed hypertrophic cardiomyopathy (wall thickness exceeding 1.7 cm)
• Severe chronic kidney disease (eGFR below 30 ml/min)
• Uncontrolled hyperthyroidism
• Stroke or transient ischemic attack (TIA) within three months before consent
• Active systemic infections
• History of cryoglobulinemia
• Diagnosed cardiac amyloidosis
• Current pregnancy
• Estimated life expectancy under one year, as judged by the treating physician
• Enrollment in another clinical study that may interfere with this trial's outcomes
• Inability or unwillingness to adhere to study requirements and follow-up visits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sebastien Knecht

OTHER

Sponsor Role: lead

Responsible Party

Sebastien Knecht

Coordinating investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sébastien Knecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan Brugge AV

Locations

AZ Sint-Jan Brugge AV

Bruges, , Belgium

UZ Brussel

Jette, , Belgium

Countries

Belgium

Central Contacts

Emma Christiaen, PhD

Role: CONTACT

emma.christiaen@azsintjan.be

+32 50453293

Facility Contacts

Emma Christiaen

Role: primary

emma.christiaen@azsintjan.be

+3250453293

Ileana Smets, MSc

Role: primary

HRMC.Research@uzbrussel.be

+32 2 477 5660

Other Identifiers

ILLUMINATE-AF

Identifier Type: -

Identifier Source: org_study_id