[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"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 electrophysiological procedure (ablation) using a reprocessed 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: Ablation - reprocessed",{"label":15,"type":16,"description":17,"interventionNames":18},"New Catheter (Active Comparator)","ACTIVE_COMPARATOR","Participants will undergo electrophysiological procedure (ablation) using a new ablation catheter. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the comparator arm.",[19],"Procedure: Ablation - new",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ablation - new","Participants will undergo electrophysiological procedure (ablation). The intervention consists of the use a new ablation catheter.\n\nThe 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],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ablation - reprocessed","Participants will undergo electrophysiological procedure (ablation). The intervention consists of the use of a reprocessed ablation catheter. 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.",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ivan Zeljković, PhD,MD","CONTACT","+385917823289","ivanzeljkov@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Mihovil Santini, MD","+385958101778","023miho@gmail.com",[42],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"UH Dubrava","Zagreb","10000","Croatia","HR",{"type":49,"coordinates":50},"Point",[51,52],15.97798,45.81444,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Ivan Zeljkovic","Principal Investigator and Head of Diagnostic and Therapeutic Department for Cardiac Electrostimulation and Electrophysiology","100633110","comparison-and-analysis-of-functionality-safety-cost-effectiveness-and-environmental-impact-of-reprocessed-and-new-ablation-catheters-in-electrophysiological-procedures-100633110",false,"NCT07522424","Comparison and Analysis of Functionality, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed and New Ablation Catheters in Electrophysiological Procedures.","RE-USE EP","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Indication for ablation 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 (or makes ablation not feasible)\n* Pregnancy or breastfeeding\n* Life expectancy \\\u003C 12 months","ALL","18 Years",{"count":68,"type":69},200,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for electrophysiological procedures. 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.",[75],"Arhythmia",[77,78,79,80,81],"Catheter Ablation","Catheter Reprocessing","Cost-Benefit Analysis","Medical Waste","Environmental Impact","NOT_YET_RECRUITING","2026-04-07",{"date":85,"type":86},"2026-04-13","ACTUAL",{"date":88,"type":69},"2026-04-30",{"date":90,"type":69},"2027-05-20",{"name":56,"class":6},1]