[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562062":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":41,"locations":50,"responsibleParty":75,"collaborators":25,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":25,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":25,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Luebeck","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SDD Group","EXPERIMENTAL","Following successful venipuncture, one or two PPS are deployed at the discretion of the operator prior to catheter insertion for catheter sheath sizes ≥ 9 French. Another PPS is deployed after catheter removal if the sheath size is \\\u003C 9 French. All sheaths are removed at the end of the ablation procedure. Hemostasis should be achieved by delivery of the suture. Protamine may be administered according to institutional standards. A vertical mattress suture (Donati suture) is applied superficially to conform to the skin tissue. The suture is removed on the first day after PVI.",[13],"Procedure: Atrial Fibrillation with femoral closure using closing system",{"label":15,"type":10,"description":16,"interventionNames":17},"ONS Group","Once the PVI block is confirmed, a figure-of-eight suture is placed at the femoral access site. The sheaths are removed and haemostasis should be achieved by manual compression at the discretion of the operator. Protamine may be administered according to institutional standards. A tourniquet is applied for a minimum of 30 minutes and the patient should remain supine.",[18],"Procedure: Atrial Fibrillation with femoral closure using figure-of-eight stitch",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Atrial Fibrillation with femoral closure using closing system","The ablation procedure will be performed under deep sedation\u002Fgeneral anaesthesia as standard of care. Vital signs will be monitored. For patients on oral anticoagulation, the procedure will be performed according to the latest guidelines. For catheter access, sheaths will be placed in the femoral veins after ultrasound-guided puncture according to institutional standard. If the patient is randomised to the SDD group prior to the procedure, the femoral access will be closed with a closure system. Ablation technique, number of access points and procedural details will be performed according to institutional standard. Patients may be enrolled regardless of the energy source used for ablation. The minimum procedural endpoint is PVI. Ablation strategies in addition to PVI are at the discretion of the operator. Antiarrhythmic therapy may be administered for a maximum of 2 months (blanking period).",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Atrial Fibrillation with femoral closure using figure-of-eight stitch","The ablation procedure will be performed under deep sedation\u002Fgeneral anaesthesia as standard of care. Vital signs will be monitored. For patients on oral anticoagulation, the procedure will be performed according to the latest guidelines. For catheter access, sheaths will be placed in the femoral veins after ultrasound-guided puncture according to institutional standard. If the patient is randomised to the ONS group prior to the procedure, the femoral access will be closed with a figure-of-eight suture. The ablation technique, number of access points and procedural details will be performed according to institutional standard. Patients may be enrolled regardless of the energy source used for ablation. The minimum procedural endpoint is PVI. Ablation strategies in addition to PVI are at the discretion of the operator. Antiarrhythmic therapy may be administered for a maximum of 2 months (blanking period).",[15],[31,35,38],{"name":32,"affiliation":33,"role":34},"Roland R Tilz, Prof. Dr.","Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":33,"role":37},"Sorin S Popescu, M.D.","STUDY_CHAIR",{"name":39,"affiliation":40,"role":37},"Mirco Kuechler, M.Sc.","Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie, Studienzentrale",[42,47],{"name":32,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","0049451500","44511","roland.tilz@uksh.de",{"name":48,"role":43,"phone":44,"phoneExt":45,"email":49},"Sorin S Popescu, MD","sorinstefan.popescu@uksh.de",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Klinik für Rhythmologie","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":60,"coordinates":61},"Point",[62,63],10.68729,53.86893,{"lat":63,"lon":62},[66,69,73],{"name":67,"role":43,"phone":44,"phoneExt":68,"email":46},"Roland R Tilz, Prof. Dr. med","44533",{"name":70,"role":43,"phone":44,"phoneExt":71,"email":72},"Mirco Kuechler","77075","mirco.kuechler@uksh.de",{"name":36,"role":74,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":34,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Roland Richard Tilz, MD","Prof. Dr. univ. med.","100562062","same-day-discharge-versus-overnight-stay-following-pulmonary-vein-isolation-for-atrial-fibrillation-100562062",false,"NCT06598280","Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation","Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study","SHAzAM-AF","Inclusion Criteria:\n\n* Patients age \\>=18 years\n* Elective catheter ablation for atrial fibrillation using 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites, independent of the energy source use\n\nExclusion Criteria:\n\n* Active systemic or cutaneous infection, or inflammation in vicinity of the groin\n* Platelet count \\\u003C 50,000 cells\u002Fmm3\n* Body mass index (BMI) \\> 45 kg\u002Fm2 or \\\u003C 18 kg\u002Fm2","ALL","18 Years",{"count":89,"type":90},270,"ESTIMATED","INTERVENTIONAL",[93],"NA","Prospective, randomized, controlled, multicentre study to compare the safety and efficacy of a Same Day Discharge (SDD) protocol in combination with a Perclose ProStyle (PPS) \u002FProGlide (PPG) suture mediated vascular closure device to the current gold standard: an overnight stay (ONS) protocol associated with manual compression ± figure-of-eight suture for the patients receiving interventional pulmonary vein isolation (PVI).",[96],"Atrial Fibrillation","2025-04-04",{"date":99,"type":100},"2025-04-08","ACTUAL",{"date":102,"type":100},"2025-02-20",{"date":104,"type":90},"2028-03-15",{"name":5,"class":6},1]