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

Official title

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

Overview

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.

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.

Primary outcome measures

• Time to first recurrence of any atrial tachyarrhythmia [Time frame: 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 [Time frame: From ablation until 30 days post ablation]
• Procedure duration (minutes) [Time frame: Day of ablation procedure]

Secondary outcome measures (7)

• Left atrial dwelling time (minutes) [Time frame: Day of ablation procedure]
• Fluoroscopy time (minutes) [Time frame: Day of ablation procedure]
• AF burden: percentage of time in AF on 7 day Holter (%) [Time frame: Before ablation, and 6 months and 12 months post ablation]
• Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%) [Time frame: From ablation until 12 months post ablation]
• Proportion of patients undergoing a repeat ablation (%) [Time frame: From ablation until 12 months post ablation]
• Quality of life changes, assessed using the 36-Item Short Form Survey Instrument (SF-36) [Time frame: 3, 6 and 12 months post ablation]
• Quality of life changes, assessed using the AF Symptom Checklist [Time frame: 3, 6 and 12 months post ablation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Belgium · 2 centers

• AZ Sint-Jan Brugge AV — Bruges
• UZ Brussel — Jette

Identifiers

NCT: NCT07156877 · ILLUMINATE-AF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗