Using a pulsed-field balloon catheter to isolate pulmonary veins for atrial fibrillation
IsoLation of PuLmonary Vein oUtcome Using a coMbIned Pulse Field Energy and ballooN cAtheTEr in Atrial Fibrillation
This trial will test whether pulsed field ablation with the VOLT balloon catheter works as well as standard thermal ablation for adults having their first pulmonary vein isolation for atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 2 sites (Bruges and 1 other locations) |
| Trial ID | NCT07156877 on ClinicalTrials.gov |
What this trial studies
The trial randomizes adults undergoing their first pulmonary vein isolation 1:1 to receive pulsed field ablation (PFA) with the novel VOLT balloon catheter or to receive standard thermal ablation (radiofrequency or cryoballoon). The main effectiveness outcome is recurrence of atrial tachyarrhythmias between 2 and 12 months after the procedure, and safety monitoring focuses on serious complications such as cardiac tamponade, stroke, and phrenic nerve injury. Procedures follow standard peri‑procedural anticoagulation and imaging practices to exclude atrial thrombus, with protocolized follow-up rhythm monitoring. The design tests whether PFA is non-inferior to thermal ablation in maintaining rhythm while comparing complication rates.
Who should consider this trial
Good fit: Adults (≥18) with documented paroxysmal or persistent atrial fibrillation (≤12 months), who are candidates for first-time pulmonary vein isolation and meet the study's anticoagulation and safety requirements, are ideal candidates.
Not a fit: Patients with prior left atrial ablation or surgery, long-standing persistent AF (>12 months), intracardiac thrombus, prior pulmonary vein stenosis or stenting, existing diaphragmatic paralysis, or other listed exclusions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the VOLT pulsed field approach could offer similar or better rhythm control with fewer thermal-related complications and potentially faster recovery.
How similar studies have performed: Early nonrandomized and small randomized studies of pulsed field ablation have shown promising efficacy and reduced collateral injury compared with thermal methods, but large randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bruges and 1 other locations
- AZ Sint-Jan Brugge AV — Bruges, Belgium (Recruiting)
- UZ Brussel — Jette, Belgium (Recruiting)
Study contacts
- Principal investigator: Sébastien Knecht, MD, PhD — AZ Sint-Jan Brugge AV
- Study coordinator: Emma Christiaen, PhD
- Email: emma.christiaen@azsintjan.be
- Phone: +32 50453293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.