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

Recruiting · NCT07389434 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Dubrava

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Atrial fibrillation

Interventions studied

Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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
Significant structural heart disease that precludes pulsed field ablation (PFA)
Pregnancy or breastfeeding
Life expectancy \< 12 months

Where it is running

1 location listed.

UH Dubrava - Zagreb, Croatia

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →