NCT07389434 Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
| NCT ID | NCT07389434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Dubrava |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-05 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-02-05 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 * Significant structural heart disease that precludes pulsed field ablation (PFA) * Pregnancy or breastfeeding * Life expectancy \< 12 months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07389434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07389434 currently recruiting?
Yes, NCT07389434 is actively recruiting participants. Contact the research team at ivanzeljkov@gmail.com for enrollment information.
Where is the NCT07389434 trial being conducted?
This trial is being conducted at Zagreb, Croatia.
Who is sponsoring the NCT07389434 clinical trial?
NCT07389434 is sponsored by University Hospital Dubrava. The trial plans to enroll 200 participants.
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