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NCT07389434: RE-USE PVI
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
NA trial testing 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 in Atrial Fibrillation (AF) in 200 participants. Currently enrolling.
30 July 2027
Quick facts
| Lead sponsor | University Hospital Dubrava |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 5 February 2026 |
| Primary completion | 30 July 2027 |
| Estimated completion | 20 August 2027 |
| Sites | 1 location across Croatia |
Drugs / interventions tested
- 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
Conditions studied
- Atrial Fibrillation (AF) — all drugs for Atrial Fibrillation (AF) →
Sponsor
University Hospital Dubrava
Who can join
18 and older, any sex, with Atrial Fibrillation (AF). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07389434
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrial Fibrillation (AF)
Currently open trials in the same condition.
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- NCT07250529 — Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF · NA · recruiting
- NCT07358611 — Non-invasive Mapping-Guided Atrial Fibrillation Ablation · NA · recruiting
- NCT07403760 — Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly · NA · recruiting
Other University Hospital Dubrava trials
Trials by the same sponsor.
- NCT07506304 — Biological Potentials in Arthroscopic All-inside Semitendinosus Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting
- NCT07339449 — Intraoperative Multimodal Monitoring as a Means in Reducing the Duration of Mechanical Ventilation in High-Risk Patients · NA · recruiting
- NCT06960629 — The Effect of ROCK Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy (PBK) · enrolling by invitation
- NCT06969586 — The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy · enrolling by invitation
- NCT06646887 — Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07389434 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Dubrava
- Last refreshed: 5 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07389434.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing