Clinical Trial

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

Study acronym: RE-USE PVI
Recruiting
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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.
Trial Details
NCT Number NCT07389434
Lead Sponsor University Hospital Dubrava
Conditions Atrial Fibrillation (AF)
Enrollment 200 participants
Start Date 2026-02-05
Primary Completion 2027-07-30 (estimated)
Study Completion 2027-08-20 (estimated)
Updated on ClinicalTrials.gov 2026-02-05