Comparison and Analysis of Functionality, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed and New Ablation Catheters in Electrophysiological Procedures.
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: Ablation - new, Ablation - reprocessed.
- Who it may be relevant to
- Registry conditions: Arhythmia. 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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Overview
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.
Detailed description
This is a prospective, randomized, controlled non-inferiority trial comparing re-sterilized (reprocessed) and new ablation catheters in electrophysiological procedures. The study will be conducted at University Hospital Dubrava, a high-volume tertiary center for cardiac electrophysiology.
Patients scheduled for electrophysiological procedures 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 groin puncture to completion of ablation. 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 ablation, the number of energy applications 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 before and 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 Ablation - new
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. - Procedure Ablation - reprocessed
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 d
Primary outcome measures
- Ablation duration [Time frame: From the start of the index ablation procedure until its completion.]
Secondary outcome measures (7)
- Acute Procedural Success [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
- Indication for ablation according to current clinical guidelines
- Written informed consent
Exclusion criteria
- Severe valvular heart disease
- Significant structural heart disease that precludes (or makes ablation not feasible)
- 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: NCT07522424 · 2026/0306