Using a pulsed-field balloon catheter to isolate pulmonary veins for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.