[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424273":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":36,"responsibleParty":166,"collaborators":168,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":174,"sex":180,"minAge":181,"maxAge":10,"enrollmentInfo":182,"targetDuration":10,"studyType":185,"phases":10,"briefSummary":186,"conditions":187,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Institut für Pharmakologie und Präventive Medizin","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase A",null,"Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and \u002F or valve surgery)\n\n* Data regarding standard of care post-operative pacing and treatment of POAF, if applicable, will be collected from time of surgery until discharge\n* No use of an external bi-atrial pacing device\n* No use of Defipace\n* In-hospital data will be collected for all patients\n* Patients that developed POAF (n=50) will be followed-up with a phone call 30 days after surgery",[13],"Other: No intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase B","Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and \u002F or valve surgery) with planned TMA implantation\n\n* In-hospital data will be collected for all patients\n* Use of the DefiPace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of POAF will be documented (n=100). These patients will be followed-up with a phone call 30 days after surgery",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"OTHER","No intervention","no intervention",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Peter Bramlage, Professor","IPPMed","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Susanne Nitz, PhD","CONTACT","+49 447185033","27","susanne.nitz@ippmed.de",[37,53,68,80,92,105,118,130,142,154],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Medical University of Vienna","RECRUITING","Vienna","1090","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],16.37208,48.20849,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":10,"phoneExt":10,"email":10},"Emilio Osorio, Dr. med.",{"facility":54,"status":39,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Universitätsklinikum Erlangen","Erlangen","Bavaria","91054","Germany","DE",{"type":45,"coordinates":61},[62,63],11.00783,49.59099,{"lat":63,"lon":62},[66],{"name":67,"role":32,"phone":10,"phoneExt":10,"email":10},"Friedrich Mellert, PD Dr.med.",{"facility":69,"status":39,"city":70,"state":56,"zip":71,"country":58,"countryCode":59,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Klinikum Nürnberg","Nuremberg","90419",{"type":45,"coordinates":73},[74,75],11.07752,49.45421,{"lat":75,"lon":74},[78],{"name":79,"role":32,"phone":10,"phoneExt":10,"email":10},"Theodor Fischlein, Prof.Dr.med.",{"facility":81,"status":39,"city":82,"state":56,"zip":83,"country":58,"countryCode":59,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"University Hospital of Würzburg","Würzburg","97080",{"type":45,"coordinates":85},[86,87],9.95121,49.79391,{"lat":87,"lon":86},[90],{"name":91,"role":32,"phone":10,"phoneExt":10,"email":10},"Mohamed Hassan",{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":58,"countryCode":59,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Oldenburg Hospital AöR \u002F Medical Campus University of Oldenburg","Oldenburg","Lower Saxony","26133",{"type":45,"coordinates":98},[99,100],8.21479,53.14039,{"lat":100,"lon":99},[103],{"name":104,"role":32,"phone":10,"phoneExt":10,"email":10},"Fritz Mellert, PD Dr. med.",{"facility":106,"status":39,"city":107,"state":108,"zip":109,"country":58,"countryCode":59,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Heart Center Dresden GmbH University Hospital","Dresden","Saxony","01307",{"type":45,"coordinates":111},[112,113],13.73832,51.05089,{"lat":113,"lon":112},[116],{"name":117,"role":32,"phone":10,"phoneExt":10,"email":10},"Tomas Madej, Dr. med.",{"facility":119,"status":39,"city":120,"state":10,"zip":121,"country":58,"countryCode":59,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Albert-Ludwigs-Universitaet Freiburg","Freiburg im Breisgau","79106",{"type":45,"coordinates":123},[124,125],7.85222,47.9959,{"lat":125,"lon":124},[128],{"name":129,"role":32,"phone":10,"phoneExt":10,"email":10},"Fatos Ballazhi, Dr. med.",{"facility":131,"status":39,"city":132,"state":10,"zip":133,"country":58,"countryCode":59,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Hannover Medical School","Hanover","30625",{"type":45,"coordinates":135},[136,137],9.73322,52.37052,{"lat":137,"lon":136},[140],{"name":141,"role":32,"phone":10,"phoneExt":10,"email":10},"Heidi Niehaus, PD Dr. med.",{"facility":143,"status":39,"city":144,"state":10,"zip":145,"country":58,"countryCode":59,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"University Hospital Jena","Jena","07747",{"type":45,"coordinates":147},[148,149],11.5899,50.92878,{"lat":149,"lon":148},[152],{"name":153,"role":32,"phone":10,"phoneExt":10,"email":10},"Hristo Kirov, Dr. med.",{"facility":155,"status":39,"city":156,"state":10,"zip":157,"country":58,"countryCode":59,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University Hospital Ulm","Ulm","89081",{"type":45,"coordinates":159},[160,161],9.99155,48.39841,{"lat":161,"lon":160},[164],{"name":165,"role":32,"phone":10,"phoneExt":10,"email":10},"Andreas Liebold, Prof.Dr.med.",{"type":167,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[169],{"name":170,"class":171},"Osypka AG","UNKNOWN","100424273","the-defipace-study-100424273",false,"NCT04804748","The DefiPace Study","Safety and Efficacy of Low-energy Electrical Cardioversion With or Without Bi-atrial Pacing in Patients With Post-operative Atrial Fibrillation in a Real World Setting - The DefiPace Study","Defipace","Inclusion Criteria:\n\n* Patient is scheduled to undergo elective open chest cardiac surgery (bypass and \u002F or valve surgery)\n* Patient is at least 18 years old\n* Patient with isolated bypass surgery is at least 70 years old\n* Patient with valve surgery is at least 60 years old\n* Patient provides written informed consent prior to the procedure\n* Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use\n\nExclusion Criteria:\n\n* Clinical history of either permanent, persistend or paroxysmal atrial fibrillation\n* Permanent pacemaker\u002Fdefibrillator, other intra-cardiac active implanted electronic devices\n* Minimally-invasive surgery\n* Recent stroke within the last 3 months\n* A history of or current endocarditis\n* Pregnacy at the time of surgery","ALL","18 Years",{"count":183,"type":184},450,"ESTIMATED","OBSERVATIONAL","Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery.\n\nThe DefiPace registry is designed in two phases\n\n1. to document the standard of care in 50 patients with atrial fibrillation (AF)\n2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients",[188],"Post-operative Atrial Fibrillation POAF","2026-03-25",{"date":191,"type":192},"2026-03-30","ACTUAL",{"date":194,"type":192},"2023-03-28",{"date":196,"type":184},"2026-08-31",{"name":5,"class":6},10]