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NCT07389434Recruiting

Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI

Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
9 Jan 2026
Start date
5 Feb 2026
Primary completion date
30 Jul 2027
Lead sponsor
University Hospital Dubrava
NCT number
NCT07389434

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 5 Feb 2026 to the primary completion date, 30 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe valvular heart disease
  • Significant structural heart disease that precludes pulsed field ablation (PFA)

Other

  • Pregnancy or breastfeeding
  • Life expectancy \< 12 months

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UH Dubrava
Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.