This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for pulmonary vein isolation in patients with atrial fibrillation. Adult patients scheduled for catheter ablation will be randomly assigned to undergo the procedure using either a new catheter or a re-sterilized catheter, with identical procedural techniques applied in both groups. The study will compare procedural efficiency, safety, costs, and environmental impact between the two approaches. The results may support more sustainable and cost-effective use of medical devices in cardiac electrophysiology.
Age ≥ 18 years
Paroxysmal or persistent atrial fibrillation documented by ECG or Holter ECG monitoring
Indication for pulmonary vein isolation according to current clinical guidelines
Written informed consent
Severe valvular heart disease
Significant structural heart disease that precludes pulsed field ablation (PFA)
Pregnancy or breastfeeding
Life expectancy < 12 months
Parallel
Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor
Procedure/SurgeryThis intervention involves pulmonary vein isolation performed with ablation catheter that is either new or reprocessed. The reprocessed catheter has undergone validated cleaning, resterilization, and functional testing in accordance with regulatory and safety standards prior to reuse. The key distinguishing feature of this intervention is the comparison of reprocessed versus new single-use catheters, while all other procedural aspects, including operator technique, energy delivery protocol, and peri-procedural care, are standardized and identical between groups.
Pulmonary Vein Isolation Procedure Duration
Procedure duration, expressed in minutes, measured from transseptal puncture to completion of ablation of all pulmonary veins. Additional procedural parameters, including duration of individual procedural segments, total ablation time, number and duration of energy applications, and other time-related procedural characteristics, will also be recorded.
Procedural Catheter Performance Parameters
Catheter functional performance assessed by successful pulmonary vein isolation, number of energy applications per pulmonary vein, total ablation time, and procedural assessment of catheter integrity and flexibility.
Medical Waste Generated Per Procedure
Amount of medical waste generated per ablation procedure, expressed in kilograms.
Fluoroscopy Time
Total fluoroscopy time, expressed in minutes, recorded during the ablation procedure.
Radiation Dose (Dose-Area Product)
Radiation exposure expressed as dose-area product (DAP), automatically recorded during the ablation procedure.
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