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Comparison and Analysis of Functionality, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed and New Ablation Catheters in Electrophysiological Procedures.
Sponsor: Ivan Zeljkovic
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-04-30
Completion Date
2027-05-20
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Ablation - new
Participants will undergo electrophysiological procedure (ablation). The intervention consists of the use a new ablation catheter. 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.
Ablation - reprocessed
Participants will undergo electrophysiological procedure (ablation). The intervention consists of the use of a reprocessed ablation catheter. 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