Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI (RE-USE PVI)

Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Participants 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

Detailed Description

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

Patients scheduled for pulmonary vein isolation 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 transseptal puncture to completion of ablation of all pulmonary veins. 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 of complete pulmonary vein isolation, the number of energy applications per pulmonary vein, 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 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
    • Recruiting
    • UH Dubrava
    • Principal Investigator: Ivan Zeljković, MD, Phd
    • Principal Investigator: Mihovil Santini, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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 Criteria:

• Severe valvular heart disease
• Significant structural heart disease that precludes pulsed field ablation (PFA)
• 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 pulmonary vein isolation using a reprocessed electroporation 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: Participants 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.
Active Comparator: New Catheter (Active Comparator); Participants will undergo pulmonary vein isolation using a new electroporation ablation catheter. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the experimental arm.	Procedure: Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Vein Isolation Procedure Duration	Procedure duration, expressed in minutes, measured from transseptal puncture to completion of ablation of all pulmonary veins. Additional procedural parameters, including duration of individual procedural segments, total ablation time, number and duration of energy applications, and other time-related procedural characteristics, will also be recorded.	From the start of the index ablation procedure until its completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Catheter Performance Parameters	Catheter functional performance assessed by successful pulmonary vein isolation, number of energy applications per pulmonary vein, total ablation time, and procedural assessment of catheter integrity and flexibility.	From the start of the index ablation procedure until its completion
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.

Collaborators and Investigators

• Sponsor: University Hospital Dubrava

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 20, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter Ablation; Cost-Benefit Analysis; Electroporation; Environmental Impact; Medical Waste; Catheter Reprocessing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 2025/1024-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, as no formal data-sharing plan has been established for this study.

Drug and device information, study documents

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