Comparison and Analysis of Functionality, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed and New Ablation Catheters in Electrophysiological Procedures.

ConditionArhythmia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIvan Zeljkovic

About this trial

This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for electrophysiological procedures. 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

Indication for ablation according to current clinical guidelines

Written informed consent

Disqualifiers

Severe valvular heart disease

Significant structural heart disease that precludes (or makes ablation not feasible)

Pregnancy or breastfeeding

Life expectancy < 12 months

Trial design

Treatments tested in this trial

  • Ablation - new
  • Ablation - reprocessed

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ivan Zeljkovic

Lead sponsor

University Hospital Dubrava

Sponsor institution