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

NCT07522424 | Not Yet Recruiting

• 1 other identifier: 2026/0306
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arhythmia

Keywords

Catheter Ablation; Catheter Reprocessing; Cost-Benefit Analysis; Medical Waste; Environmental Impact

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Acute Procedural Success

  From the start of the index ablation procedure until its completion

• Medical Waste Generated Per Procedure

  Periprocedural

• Fluoroscopy Time

  From the start of the index ablation procedure until its completion

• Radiation Dose (Dose-Area Product)

  From the start of the index ablation procedure until its completion

• Incidence of Peri- and Post-Procedural Complications

  Up to 30 days following the index ablation procedure

Study Arms (2)

Reprocessed Catheter (Experimental)

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

New Catheter (Active Comparator)

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

Interventions

Ablation - new PROCEDURE

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.

New Catheter (Active Comparator)

Ablation - reprocessed PROCEDURE

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.

Reprocessed Catheter (Experimental)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ivan Zeljkovic: lead

Study Sites (1)

UH Dubrava

Zagreb, 10000, Croatia

Location

Central Study Contacts

Ivan Zeljković, PhD,MD

CONTACT

+385917823289; ivanzeljkov@gmail.com

Mihovil Santini, MD

CONTACT

+385958101778; 023miho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Head of Diagnostic and Therapeutic Department for Cardiac Electrostimulation and Electrophysiology

Model Details: The study is designed as a prospective, randomized, controlled non-inferiority trial with a parallel-group design, comparing resterilized (reprocessed) and new ablation catheters used in electrophysiological procedures. Participants will be randomly assigned to two groups, with one group undergoing ablation using new catheters and the other using resterilized catheters, while the procedural protocol will be identical in both groups. The primary endpoint is procedure duration, expressed in minutes. Secondary endpoints include catheter functionality, fluoroscopy time and radiation dose, peri- and post-procedural complications, procedural safety, procedural costs, and assessment of environmental impact.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 13, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)