Actively Recruiting
Isolation of Pulmonary Vein Outcome Using Combined Pulsed Field Energy and Balloon Catheter in Atrial Fibrillation
Led by Sebastien Knecht · Updated on 2026-05-12
136
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying atrial fibrillation (AF) in adults who are undergoing their first pulmonary vein isolation (PVI) procedure. The trial compares a new method called pulsed field ablation (PFA) using the VOLT catheter to conventional thermal ablation techniques, such as radiofrequency or cryotherapy. The goal is to see if PFA is as safe and effective as thermal ablation in preventing irregular heart rhythms and serious complications like cardiac tamponade, stroke, or nerve injury. Participants are randomly assigned to one of two groups. One group will receive PFA with the VOLT catheter, which uses non-thermal pulsed energy delivered by a balloon-in-basket catheter compatible with mapping systems. The other group will receive thermal ablation, either by radiofrequency point-by-point ablation or cryoballoon freezing. Procedures are done under sedation or anesthesia following standard protocols. The study lasts three years, including two years of enrollment and one year of follow-up for each participant. During the study, participants have follow-up visits at 2-3 months, 6 months, and 12 months after the procedure. Heart rhythm is monitored with repeated ECGs, Holter monitors, and weekly home ECG recordings using a Kardia Mobile device in the final three months. Quality of life is assessed using questionnaires at baseline and at 3, 6, and 12 months. Researchers will measure time to arrhythmia recurrence, safety events within 30 days, procedure duration, and other heart function and quality of life outcomes.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Paroxysmal or persistent atrial fibrillation documented on ECG or Holter monitor within the last 24 months
- Candidate for ablation based on current atrial fibrillation guidelines
- On continuous anticoagulation for at least 4 weeks prior to ablation or recent imaging excluding left atrial thrombus
- Able and willing to provide 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 conditions
- Presence of thrombus inside heart chambers
- Previous pulmonary vein stenosis or stenting
- Existing diaphragm paralysis on one side
- Allergy or contraindication to anticoagulants or contrast agents
- History of mitral valve surgery or significant mitral valve disease
- Recent myocardial infarction within 3 months
- Currently on triple antithrombotic therapy
- Recent or planned cardiac surgery or TAVI
- Major congenital heart abnormalities
- Congestive heart failure classified as NYHA class III or IV
- Left ventricular ejection fraction less than 35%
- 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
- Active systemic infections
- History of cryoglobulinemia
- Cardiac amyloidosis diagnosis
- Current pregnancy
- Life expectancy less than one year
- Participation in another clinical trial that may interfere
- Inability or unwillingness to comply with study visits and requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Day of ablation procedure
Participants undergo pulmonary vein isolation using either the novel pulsed field ablation with the VOLT catheter or conventional thermal ablation techniques (radiofrequency or cryoballoon). The procedure is performed under conscious sedation or general anesthesia following standard protocols.
1 procedure visit (in-person)
Duration - Up to 12 months post ablation
Participants are monitored for safety and effectiveness outcomes including recurrence of atrial tachyarrhythmia, procedure-related safety events, and quality of life changes.
Visits at 3, 6, and 12 months post ablation with additional monitoring including 7-day Holter recordings before ablation, and at 6 and 12 months
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
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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