[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553480":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":40,"locations":49,"responsibleParty":118,"collaborators":120,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":18,"enrollmentInfo":136,"targetDuration":18,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":52,"whyStopped":18,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Left Posterior Pericardiotomy Group","EXPERIMENTAL","The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery.",[13],"Procedure: Left Posterior Pericardiotomy",{"label":15,"type":16,"description":17,"interventionNames":18},"No Posterior Pericardiotomy Group","NO_INTERVENTION","The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Left Posterior Pericardiotomy","The surgeon will perform a left posterior pericardiotomy while the patient is on cardiopulmonary bypass. A soft channel drain will be put into place at an angle directed toward the posterior pericardium. The surgeon will grasp the pericardium and use cautery to make a 4- to 5-cm opening between the left inferior pulmonary vein and the diaphragm. The previously prepared channel drain is cut to the desired length and placed through the pericardiotomy along the diaphragm and into the pleural space.",[9],[26,29,31,34,37],{"name":27,"affiliation":5,"role":28},"Richard Whitlock","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Emilie Belley-Côté",{"name":32,"affiliation":33,"role":28},"Mario Gaudino","Weill Medical College of Cornell University",{"name":35,"affiliation":36,"role":28},"Sigrid Sandner","Medical University Vienna",{"name":38,"affiliation":39,"role":28},"Björn Redfors","Göteborg University",[41,46],{"name":27,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","9055274322","40306","Richard.Whitlock@phri.ca",{"name":47,"role":42,"phone":18,"phoneExt":18,"email":48},"PRINCE Coordinators","PRINCE@phri.ca",[50,68,84,102],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Weill Cornell Medicine","RECRUITING","New York","10065","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-74.00597,40.71427,{"lat":61,"lon":60},[64],{"name":65,"role":42,"phone":66,"phoneExt":18,"email":67},"Dr. Mario Gaudino, MD, PhD","212-746-1815","mfg9004@med.cornell.edu",{"facility":36,"status":52,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Vienna","State of Vienna","1090","Austria","AT",{"type":58,"coordinates":75},[76,77],16.37208,48.20849,{"lat":77,"lon":76},[80],{"name":81,"role":42,"phone":82,"phoneExt":18,"email":83},"Dr. Sigrid Sandner, MD","+43 (0)1 40400-69895","sigrid.sandner@meduniwien.ac.at",{"facility":85,"status":52,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Hamilton Health Sciences","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":58,"coordinates":92},[93,94],-79.84963,43.25011,{"lat":94,"lon":93},[97],{"name":98,"role":42,"phone":99,"phoneExt":100,"email":101},"Emilie Belley-Côté, MD, PhD, FRCPC","(905) 527-4322","41147","Emilie.Belley-Cote@phri.ca",{"facility":103,"status":52,"city":104,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University of Foggia, Policlinico Foggia","Foggia","71122","Italy","IT",{"type":58,"coordinates":109},[110,111],15.55188,41.45845,{"lat":111,"lon":110},[114],{"name":115,"role":42,"phone":116,"phoneExt":18,"email":117},"Prof. Domenico Paparella, MD, PHD","+39 0881 736145","domenico.paparella@unifg.it",{"type":119,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[121,123,125],{"name":122,"class":6},"McMaster University",{"name":124,"class":6},"Hamilton Health Sciences Corporation",{"name":33,"class":6},"100553480","pericardiotomy-in-cardiac-surgery-100553480",false,"NCT06486636","Pericardiotomy in Cardiac Surgery","Pericardiotomy in Cardiac Surgery Trial","PRINCE","Inclusion Criteria:\n\n* Patients greater than or equal to 18 years of age\n* Requiring surgical intervention on the proximal aorta, cardiac valves, and\u002For coronary arteries\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* History of atrial fibrillation or flutter\n* Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, aortic arch, transplantation surgery)\n* Prior cardiac surgery requiring opening of the pericardium\n* Previous surgical instrumentation of the left pleural cavity\n* Patient undergoing minimally invasive cardiac surgery","ALL","18 Years",{"count":137,"type":138},1400,"ESTIMATED","INTERVENTIONAL",[141],"NA","PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.",[144,145,146],"Atrial Fibrillation","Atrial Flutter","Cardiac Events",[148,149,150,151],"Pericardiotomy","Cardiac Surgery","Hospital Readmission","Post-Operative Atrial Fibrillation","2025-07-09",{"date":154,"type":155},"2025-07-14","ACTUAL",{"date":157,"type":155},"2024-10-21",{"date":159,"type":138},"2031-09-01",{"name":5,"class":6},4]