[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clinica Mediterranea\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100498999","af-ablation-with-high-power-short-duration-rf-100498999",false,"NCT05777551","AF Ablation With High Power Short Duration RF","Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)","AIR HPSD","Inclusion Criteria:\n\n* Patients with paroxysmal\u002Fpersistent AF who signed the informed consent\n* Patients on active oral anticoagulation\n\nExclusion Criteria:\n\n* Previous ablation for AF\n* Patients with LVEF\\\u003C35%\n* Women potentially pregnant\n* Contraindications to X-ray exposure\n* Congenital heart disease or cardiac surgery within 1 month","ALL","18 Years","80 Years",{"count":21,"type":22},850,"ESTIMATED","12 Months","OBSERVATIONAL","This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal\u002Fpersistent atrial fibrillation (AF).\n\nSubjects with paroxysmal\u002Fpersistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters).\n\nPatients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD.\n\nAt least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.",[27,28],"Atrial Fibrillation","Catheter Ablation","RECRUITING","2024-03-02",{"date":32,"type":33},"2024-03-05","ACTUAL",{"date":35,"type":33},"2023-01-01",{"date":37,"type":22},"2027-12-31",{"name":39,"class":40},"Clinica Mediterranea","OTHER",9,""]