Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
Recruiting
N/A
Interventional Study
Atrial Fibrillation (AF)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- University Hospital Dubrava · Other
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About This Trial
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 app…
Trial Locations
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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
* Signif…
Contacts