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

University Hospital Dubrava

Status: Enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07389434

2025/1024-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Reprocessed Catheter (Experimental)

Experimental group

Description:

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.

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

New Catheter (Active Comparator)

Active Comparator group

Description:

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.

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