Testing Reused Heart Catheters in Atrial Fibrillation Procedures
Compares reprocessed and new ablation catheters for treating atrial fibrillation in adult patients.
Plain-language title generated from the registry record
Registry title: Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
Key facts
- Where
- Zagreb, CroatiaSee the site
Where in Croatia
- UH DubravaZagreb, CroatiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Dubrava
- Trial code
- NCT07389434
- Record updated
- 5 February 2026
- Original description
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.Read full original descriptionShow less
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation
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.
Inclusion: 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: Severe valvular heart disease; Significant structural heart disease that precludes pulsed field ablation (PFA); Pregnancy or breastfeeding; Life expectancy < 12 months.