[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622885":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University Hospital Dubrava","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reprocessed Catheter (Experimental)","EXPERIMENTAL","Participants will undergo pulmonary vein isolation using a reprocessed electroporation ablation catheter. The catheter has undergone validated cleaning, re-sterilization, and functional testing in accordance with applicable regulatory and safety standards. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the comparator arm.",[13],"Procedure: 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",{"label":15,"type":16,"description":17,"interventionNames":18},"New Catheter (Active Comparator)","ACTIVE_COMPARATOR","Participants will undergo pulmonary vein isolation using a new electroporation ablation catheter. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the experimental arm.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","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","This intervention involves pulmonary vein isolation performed with ablation catheter that is either new or reprocessed. The reprocessed catheter has undergone validated cleaning, resterilization, and functional testing in accordance with regulatory and safety standards prior to reuse. The key distinguishing feature of this intervention is the comparison of reprocessed versus new single-use catheters, while all other procedural aspects, including operator technique, energy delivery protocol, and peri-procedural care, are standardized and identical between groups.",[15,9],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Ivan Zeljković, PhD,MD","CONTACT","+385917823289","ivanzeljkov@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},"Mihovil Santini, MD","+385958101778","023miho@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"UH Dubrava","RECRUITING","Zagreb","10000","Croatia","HR",{"type":45,"coordinates":46},"Point",[47,48],15.97798,45.81444,{"lat":48,"lon":47},[51,54],{"name":52,"role":53,"phone":25,"phoneExt":25,"email":25},"Ivan Zeljković, MD, Phd","PRINCIPAL_INVESTIGATOR",{"name":33,"role":53,"phone":25,"phoneExt":25,"email":25},{"type":53,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ivan Zeljkovic","Principal Investigator and Head of Diagnostic and Therapeutic Department for Cardiac Electrostimulation and Electrophysiology","100622885","feasibility-safety-cost-effectiveness-and-environmental-impact-of-reprocessed-ablation-catheters-in-pvi-100622885",false,"NCT07389434","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","RE-USE PVI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Paroxysmal or persistent atrial fibrillation documented by ECG or Holter ECG monitoring\n* Indication for pulmonary vein isolation according to current clinical guidelines\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe valvular heart disease\n* Significant structural heart disease that precludes pulsed field ablation (PFA)\n* Pregnancy or breastfeeding\n* Life expectancy \\\u003C 12 months","ALL","18 Years",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.",[76],"Atrial Fibrillation (AF)",[78,79,80,81,82,83,84],"Atrial Fibrillation","Catheter Ablation","Electroporation","Catheter Reprocessing","Cost-Benefit Analysis","Medical Waste","Environmental Impact","2026-01-31",{"date":87,"type":88},"2026-02-05","ACTUAL",{"date":87,"type":70},{"date":91,"type":70},"2027-08-20",{"name":5,"class":6},1]