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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arhythmia
• Intervention / Treatment: Procedure: Ablation - reprocessed; Procedure: Ablation - new

Detailed Description

This is a prospective, randomized, controlled non-inferiority trial comparing re-sterilized (reprocessed) and new ablation catheters in electrophysiological procedures. The study will be conducted at University Hospital Dubrava, a high-volume tertiary center for cardiac electrophysiology.

Patients scheduled for electrophysiological procedures will be randomized in a 1:1 ratio using a computer-generated sequence to undergo ablation with either a new or a re-sterilized catheter. All procedures will be performed by experienced electrophysiologists in accordance with standard institutional practice.

Procedure duration will be measured from groin puncture to completion of ablation. Additional procedural parameters related to ablation delivery, including duration and number of energy applications, total ablation time, and other procedural timing characteristics, will also be recorded. Fluoroscopy time and radiation dose, expressed as dose-area product (DAP), will be recorded automatically.

Catheter performance will be assessed based on achievement ablation, the number of energy applications and procedural assessment of catheter integrity, flexibility, and electrical properties.

Procedural safety will be evaluated by monitoring peri-procedural and post-procedural adverse events, including pericardial effusion, stroke, vascular complications, and death. Laboratory markers of inflammation, infection, and hemolysis will be obtained at predefined time points before and after the procedure. Blood cultures will be collected before and after the procedure to assess potential infectious complications.

Patients will be followed clinically during hospitalization and after discharge through telephone contact and routine outpatient visits.

Economic evaluation will include direct procedural costs, catheter costs, and re-sterilization costs. Environmental impact will be assessed based on medical waste generation and estimated carbon footprint associated with catheter use.

Re-sterilization of ablation catheters will be performed according to the validated internal protocol of University Hospital Dubrava, which has been used in routine clinical practice.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Zeljković, PhD,MD; Phone Number: +385917823289; Email: ivanzeljkov@gmail.com
• Study Contact Backup: Name: Mihovil Santini, MD; Phone Number: +385958101778; Email: 023miho@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • UH Dubrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Indication for ablation according to current clinical guidelines
• Written informed consent

Exclusion Criteria:

• Severe valvular heart disease
• Significant structural heart disease that precludes (or makes ablation not feasible)
• Pregnancy or breastfeeding
• Life expectancy < 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reprocessed Catheter (Experimental); Participants will undergo electrophysiological procedure (ablation) using a reprocessed ablation catheter. The catheter has undergone validated cleaning, re-sterilization, and functional testing in accordance with applicable regulatory and safety standards. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the comparator arm.	Procedure: 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.
Active Comparator: New Catheter (Active Comparator); Participants will undergo electrophysiological procedure (ablation) using a new ablation catheter. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the comparator arm.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation duration	Procedure duration, expressed in minutes, measured from groin puncture to completion of ablation.	From the start of the index ablation procedure until its completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Waste Generated Per Procedure	Amount of medical waste generated per ablation procedure, expressed in kilograms.	Periprocedural
Fluoroscopy Time	Total fluoroscopy time, expressed in minutes, recorded during the ablation procedure.	From the start of the index ablation procedure until its completion
Radiation Dose (Dose-Area Product)	Radiation exposure expressed as dose-area product (DAP), automatically recorded during the ablation procedure.	From the start of the index ablation procedure until its completion
Incidence of Peri- and Post-Procedural Complications	Number of participants with peri-procedural and post-procedural complications, including pericardial effusion, stroke, vascular complications, and death.	Up to 30 days following the index ablation procedure
Direct Procedural Costs Per Patient	Direct procedural costs per patient, including catheter cost, procedure-related costs, and re-sterilization costs, expressed in local currency.	Periprocedural
Estimated Carbon Footprint Per Procedure	Estimated carbon footprint associated with the ablation procedure and catheter use, expressed in CO₂-equivalent units.	From the start of the index ablation procedure until its completion.
Acute Procedural Success	Successful completion of ablation defined as achievement of electrical isolation of the target tissue	From the start of the index ablation procedure until its completion

Collaborators and Investigators

• Sponsor: Ivan Zeljkovic

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Catheter Ablation; Cost-Benefit Analysis; Environmental Impact; Medical Waste; Catheter Reprocessing
• Other Study ID Numbers: 2026/0306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No