[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660103":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":20,"interventions":26,"overallOfficials":20,"centralContacts":31,"locations":20,"responsibleParty":41,"collaborators":20,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":20,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":20,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":20,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":20},{"fullName":5,"class":6},"CardioFocus","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":20},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Safety Outcome","Safety will be assessed through the collection of cardiovascular related, procedure related, and\u002For device related adverse events (AEs) reported by the participating sites from the day of the index procedure through study exit.","24 months",{"measure":14,"description":15,"timeFrame":16},"Efficacy Outcome Acute Success","Acute procedure success, defined as PVI of all targeted pulmonary veins using the CENTAURI System.","at the end of the index ablation procedure",{"measure":18,"description":19,"timeFrame":12},"Efficacy Outcome Chronic Success","Freedom from documented AF\u002FAT\u002FAFL from 61 days through 24 months of follow-up, clinically assessed by standard of care rhythm monitoring at participating sites.",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"CASE_ONLY","PROSPECTIVE","The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System when used with three commercially available ablation catheters (i.e., Abbott TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, Boston Scientific INTELLANAV STABLEPOINT™, Biosense Webster THERMOCOOL SMARTTOUCH™) in standard clinical practice to treat adult patients with paroxysmal AF.","Adult patients diagnosed with paroxysmal AF indicated for an ablation procedure according to society guidelines or participating site practice",[27],{"type":28,"name":29,"description":30,"armGroupLabels":20,"otherNames":20},"DEVICE","CENTAURI System in conjunction with commercially available ablation catheters","Pulsed Field Ablation using the CENTAURI System",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":20,"email":36},"Vikramaditya Mediratta, MS","CONTACT","714-717-2376","vmediratta@cardiofocus.com",{"name":38,"role":34,"phone":39,"phoneExt":20,"email":40},"Tine Wouters","+32 498 774371","twouters@cardiofocus.com",{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100660103","centauri-post-market-clinical-registry-100660103",false,"NCT07874048","CENTAURI Post-Market Clinical Registry","CENTAURI Regis","Inclusion Criteria:\n\n1. Patients diagnosed with paroxysmal AF and indicated for an ablation procedure according to society guidelines or participating site practice\n2. Age ≥18 years of age\n3. Patient is willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Patients who have had an atriotomy within the preceding eight weeks as the recent surgery may increase the risk of perforation\n2. Patients with a prosthetic heart valve, in which the catheter may pass through, as the catheter may damage the prosthesis\n3. Patients with active systemic infection, as this may increase the risk for cardiac infection\n4. Patients with an atrial myxoma or intracardiac thrombus as the catheter could precipitate an embolus\n5. Patients with an interatrial baffle or patch as the opening could persist and produce an iatrogenic atrial shunt\n6. In patients who have vena cava embolic protection filter devices and\u002For known femoral thrombus who require catheter insertion from the femoral approach\n7. In patients who are hemodynamically unstable, as per physician discretion","ALL","18 Years",{"count":53,"type":54},300,"ESTIMATED","24 Months","OBSERVATIONAL","The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System",[59],"Paroxysmal AF",[59,61,62],"PFA","Pulsed Field Ablation","NOT_YET_RECRUITING","2026-10-08",{"date":66,"type":67},"2026-10-14","ACTUAL",{"date":69,"type":54},"2026-12",{"date":71,"type":54},"2029-12",{"name":5,"class":6}]