About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Severe valvular heart disease
Significant structural heart disease that precludes pulsed field ablation (PFA)
Pregnancy or breastfeeding
Life expectancy < 12 months
Trial design
Treatments tested in this trial
- 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