Atrial Fibrillation (AF)
Conditions
Keywords
Atrial fibrillation, Pulmonary vein isolation, Pulsed field ablation
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.
Interventions
PROCEDUREPulsed 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.
PROCEDUREThermal 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
Sebastien Knecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrence of any atrial tachyarrhythmia | Between 2 and 12 months post ablation | 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. |
| Number of safety events, composite of cardiac tamponade, phrenic nerve palsy, vascular complications, stroke/transient ischemic attack, atrio-esophageal fistula and death | From ablation until 30 days post ablation | 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. |
| Procedure duration (minutes) | Day of ablation procedure | Total procedure duration (minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%) | From ablation until 12 months post ablation | Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%) |
| Proportion of patients undergoing a repeat ablation (%) | From ablation until 12 months post ablation | Proportion of patients undergoing a repeat ablation (%) |
| Left atrial dwelling time (minutes) | Day of ablation procedure | Time the catheter remains inside the left atrium during the ablation procedure (minutes) |
| Quality of life changes, assessed using the AF Symptom Checklist | 3, 6 and 12 months post ablation | Quality of life changes at 3, 6 and 12 months compared with baseline, assessed using the AF Symptom Checklist |
| Quality of life changes, assessed using the 36-Item Short Form Survey Instrument (SF-36) | 3, 6 and 12 months post ablation | Quality of life changes at 3, 6 and 12 months compared with baseline, assessed using the 36-Item Short Form Survey Instrument (SF-36) |
| Fluoroscopy time (minutes) | Day of ablation procedure | Total fluoroscopy time (minutes) |
| AF burden: percentage of time in AF on 7 day Holter (%) | Before ablation, and 6 months and 12 months post ablation | AF burden: percentage of time in AF on 7 day Holter (%) |
Countries
Belgium
Contacts
CONTACTEmma Christiaen, PhD
PRINCIPAL_INVESTIGATORSébastien Knecht, MD, PhD
AZ Sint-Jan Brugge AV
Outcome results
None listed