Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI

NCT07389434 | Recruiting

• 1 other identifier: 2025/1024-3
• 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 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.

Conditions

Atrial Fibrillation (AF)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Procedural Catheter Performance Parameters

  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 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

New Catheter (Active Comparator)

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

Interventions

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 PROCEDURE

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.

New Catheter (Active Comparator); 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
• 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

You may not qualify if:

• Severe valvular heart disease
• Significant structural heart disease that precludes pulsed field ablation (PFA)
• Pregnancy or breastfeeding
• Life expectancy \< 12 months

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

UH Dubrava

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: PRINCIPAL 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 electroporation ablation catheters used for pulmonary vein isolation in patients with atrial fibrillation. 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: January 9, 2026
• First Posted: February 5, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)