Actively Recruiting
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
Led by University Hospital Dubrava · Updated on 2026-02-05
200
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E= 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 will not qualify if you...
- Severe valvular heart disease
- Significant structural heart disease that precludes pulsed field ablation
- Pregnancy or breastfeeding
- Life expectancy < 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
UH Dubrava
Zagreb, Croatia, 10000
Actively Recruiting
Research Team
I
Ivan Zeljković, PhD,MD
CONTACT
M
Mihovil Santini, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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