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

RecruitingNAAges 18 Years - anyAllUniversity Hospital Dubrava
NCT07389434 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

1 site
UH Dubrava
Zagreb, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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