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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Dubrava

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

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators