RecruitingNot ApplicableNCT07389434

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

Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation

Sponsor

University Hospital Dubrava

Enrollment

200 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing reprocessed (cleaned and recertified for reuse) ablation catheters to brand-new catheters for a heart procedure called pulmonary vein isolation (PVI) — a technique used to treat atrial fibrillation by electrically disconnecting problem areas in the heart. The goal is to see if reused catheters are equally safe, effective, and more environmentally friendly. **You may be eligible if...** - You are 18 years of age or older - You have atrial fibrillation (paroxysmal or persistent) confirmed by ECG or heart monitor - You have been recommended for pulmonary vein isolation according to current clinical guidelines - You have given written informed consent **You may NOT be eligible if...** - You have severe valve disease - You have structural heart disease that prevents use of the ablation technique used in this study - You are pregnant or breastfeeding - Your life expectancy is less than 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREParticipants 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

This intervention involves pulmonary vein isolation performed with ablation catheter that is either new or reprocessed. The reprocessed catheter has undergone validated cleaning, resterilization, and functional testing in accordance with regulatory and safety standards prior to reuse. The key distinguishing feature of this intervention is the comparison of reprocessed versus new single-use catheters, while all other procedural aspects, including operator technique, energy delivery protocol, and peri-procedural care, are standardized and identical between groups.

Locations(1)

UH Dubrava

Zagreb, Croatia

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NCT07389434

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