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

Inclusion Criteria4

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 Criteria4

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

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.