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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ablation - new

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Reprocessed Catheter (Experimental)Experimental treatment 1 intervention
Group B: New Catheter (Active Comparator)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ablation duration

Procedure duration, expressed in minutes, measured from groin puncture to completion of ablation.

Time frame
From the start of the index ablation procedure until its completion.

Secondary outcomes

1

Acute Procedural Success

Successful completion of ablation defined as achievement of electrical isolation of the target tissue

Time frame
From the start of the index ablation procedure until its completion
2

Medical Waste Generated Per Procedure

Amount of medical waste generated per ablation procedure, expressed in kilograms.

Time frame
Periprocedural
3

Fluoroscopy Time

Total fluoroscopy time, expressed in minutes, recorded during the ablation procedure.

Time frame
From the start of the index ablation procedure until its completion
4

Radiation Dose (Dose-Area Product)

Radiation exposure expressed as dose-area product (DAP), automatically recorded during the ablation procedure.

Time frame
From the start of the index ablation procedure until its completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ivan Zeljkovic

Lead sponsor

University Hospital Dubrava

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: