Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI

Summary

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

Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe valvular heart disease
* Significant structural heart disease that precludes pulsed field ablation (PFA)
* Pregnancy or breastfeeding
* Life expectancy \< 12 months

Conditions2

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