Atrial fibrillation Atrial fibrillation
Conditions
Interventions
PVI will be performed using the CE-marked VARIPULSE™ pulsed field ablation (PFA) catheter system, applied according to the manufacturer’s recommended settings and current clinical practice. The system
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 years of ageAF and eligible for index PVI according to current ESC guidelines.
Exclusion criteria
Exclusion criteria: Unwilling or unable to give written informed consentPrior left atrial ablationOther left atrial arrhythmias including atrial fluttersPrior left atrial surgerySevere mitral valve regurgitationContraindication for gadolinium-based contrast agentsContraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia) Renal insufficiency (eGFR < 30 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure duration, defined as the time from the first PFA application to the final PFA application during the PVI procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ablation lesion characteristics on CMR.Procedural fluoroscopy metrics, including total fluoroscopy time and radiation dose.Acute procedural efficacy, expressed as the percentage of direct isolation achieved for each pulmonary vein.Acute pulmonary vein reconnection, assessed per vein.Clinical efficacy, defined as the percentage of patients free from atrial tachyarrhythmias at 12-month follow-up.Safety outcomes. | — |
Countries
Netherlands
Contacts
Public ContactCP Allaart
Radboud Universitair Medisch Centrum
Outcome results
None listed