Actively Recruiting
Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
Led by Sebastien Knecht · Updated on 2026-05-12
136
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Paroxysmal or persistent atrial fibrillation documented on 12 lead ECG or Holter monitor lasting 30 seconds or more within the last 24 months
- Candidate for ablation based on current atrial fibrillation guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or NOAC for at least 4 weeks before ablation; or TEE and/or CT excluding left atrial thrombus within 48 hours before ablation
- Age 18 years or older at consent
- Signed informed consent
You will not qualify if you...
- History of left atrial ablation or surgery involving the left atrium
- Persistent atrial fibrillation lasting longer than 12 months
- Atrial fibrillation caused by temporary or reversible causes
- Presence of thrombus in heart chambers
- Prior pulmonary vein stenosis or stenting
- Paralysis of one side of the diaphragm
- Allergy or contraindication to anticoagulants or contrast agents
- History of mitral valve surgery
- Significant mitral valve disease
- Myocardial infarction within 3 months before consent
- Current use of triple antithrombotic therapy
- Cardiac surgery within past 3 months or scheduled cardiac surgery or TAVI
- Major congenital heart abnormalities
- Congestive heart failure NYHA class III or IV
- Left ventricular ejection fraction below 35%
- Diagnosed hypertrophic cardiomyopathy with wall thickness over 1.7 cm
- Severe chronic kidney disease with eGFR below 30 ml/min
- Uncontrolled hyperthyroidism
- Stroke or transient ischemic attack within 3 months before consent
- Active systemic infections
- History of cryoglobulinemia
- Diagnosed cardiac amyloidosis
- Current pregnancy
- Life expectancy less than one year as judged by physician
- Participation in another clinical study that may interfere
- Inability or unwillingness to follow study requirements and attend visits
AI-Screening
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Trial Site Locations
Total: 2 locations
1
AZ Sint-Jan Brugge AV
Bruges, Belgium, 8000
Actively Recruiting
2
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
Research Team
E
Emma Christiaen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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