Status:
NOT_YET_RECRUITING
Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
Lead Sponsor:
Sebastien Knecht
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Phase:
NA
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 cryotherap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT07156877
Start Date
November 1 2025
End Date
November 1 2028
Last Update
September 5 2025
Active Locations (2)
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1
AZ Sint-Jan Brugge AV
Bruges, Belgium, 8000
2
UZ Brussel
Jette, Belgium, 1090