Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation
Overview
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.
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.
Interventions
- 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
Primary outcome measures
- Pulmonary Vein Isolation Procedure Duration [Time frame: From the start of the index ablation procedure until its completion.]
Secondary outcome measures (7)
- Procedural Catheter Performance Parameters [Time frame: From the start of the index ablation procedure until its completion]
- Medical Waste Generated Per Procedure [Time frame: Periprocedural]
- Fluoroscopy Time [Time frame: From the start of the index ablation procedure until its completion]
- Radiation Dose (Dose-Area Product) [Time frame: From the start of the index ablation procedure until its completion]
- Incidence of Peri- and Post-Procedural Complications [Time frame: Up to 30 days following the index ablation procedure]
- Direct Procedural Costs Per Patient [Time frame: Periprocedural]
- Estimated Carbon Footprint Per Procedure [Time frame: From the start of the index ablation procedure until its completion.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Croatia · 1 center
- UH Dubrava — Zagreb
Identifiers
NCT: NCT07389434 · 2025/1024-3