[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493901":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":33,"locations":40,"responsibleParty":61,"collaborators":22,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":22,"enrollmentInfo":73,"targetDuration":22,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":43,"whyStopped":22,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Structured SDM","Structured shared decision making for the choice between SAVR and TAVR",[12],"Other: Structured SDM",{"label":14,"type":6,"description":15,"interventionNames":16},"Usual Care","Usual care for the choice between SAVR and TAVR",[17],"Other: Usual Care",[19,23],{"type":6,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"The conversation between the heart team member and the patient will be structured according the adapted three-talk model for patients with symptomatic aortic stenosis and using the American College of Cardiology's decision aid for patients deciding between TAVR and SAVR",[9],null,{"type":6,"name":14,"description":24,"armGroupLabels":25,"otherNames":22},"Usual care will include baseline visits without a structured SDM approach. Usual care includes at least one decision making talk with a heart team member discussing information about the disease, treatment options as well as benefits and risks of each procedure.",[14],[27,31],{"name":28,"affiliation":29,"role":30},"Thomas Pilgrim, Prof.","Department of Cardiology, University Hospital Bern, Inselspital, Bern","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":29,"role":30},"Christoph Ryffel, Dr. med.",[34,38],{"name":28,"role":35,"phone":36,"phoneExt":22,"email":37},"CONTACT","+41 31 632 50 00","thomas.pilgrim@insel.ch",{"name":32,"role":35,"phone":36,"phoneExt":22,"email":39},"christoph.ryffel@insel.ch",[41],{"facility":42,"status":43,"city":44,"state":22,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Bern University Hospital, Dep. of Cardiology","RECRUITING","Bern","3010","Switzerland","CH",{"type":49,"coordinates":50},"Point",[51,52],7.44744,46.94809,{"lat":52,"lon":51},[55,56,57,58],{"name":28,"role":35,"phone":36,"phoneExt":22,"email":37},{"name":28,"role":30,"phone":22,"phoneExt":22,"email":22},{"name":32,"role":30,"phone":22,"phoneExt":22,"email":22},{"name":59,"role":60,"phone":22,"phoneExt":22,"email":22},"Jonas Lanz, PD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100493901","structured-shared-decision-making-for-patients-undergoing-savr-or-tavr-100493901",false,"NCT05711186","Structured Shared Decision Making for Patients Undergoing SAVR or TAVR","Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial","TOGETHER","Inclusion Criteria:\n\n1. Age ≥ 70 years\n2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \\\u003C0.6cm2\u002Fm2\n3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 year irrespective of valvular heart disease\n2. Inability to provide informed consent\n3. Participation in another clinical trial with an active intervention","ALL","70 Years",{"count":74,"type":75},140,"ESTIMATED","INTERVENTIONAL",[78],"NA","Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.\n\nThe objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.\n\nTOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.",[81,82],"Aortic Valve Stenosis","Symptomatic Aortic Stenosis",[82,81,84,85,86,87,88],"SAVR (Surgical Aortic Valve Replacement)","Shared Decision-Making","TAVR (Transcatheter Aortic Valve Replacement)","TAVI (Transcatheter Aortic Valve Implantation)","Decision Support Techniques","2026-05-07",{"date":91,"type":92},"2026-05-08","ACTUAL",{"date":94,"type":92},"2023-04-17",{"date":96,"type":75},"2027-12-31",{"name":5,"class":6},1]