[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565137":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":25,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute TAVI","EXPERIMENTAL","Acute TAVI within 12 hours.",[13],"Procedure: Acute TAVI",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard treatment","ACTIVE_COMPARATOR","TAVI no earlier than 72 hours.",[19],"Other: Stabilization and subacute TAVI",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Stabilization and subacute TAVI","Patients are stabilized according to target parameters. Treatment may include vasopressor, mechanical ventilation, renal replacement therapy, and blood transfusion. TAVI is then performed no earlier than 72 hours of admission to heart center.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Emil L Fosbøl, Professor, MD, PhD","CONTACT","004535456340","emil.fosboel@regionh.dk",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Jarl E Strange, MD, PhD","004560616598","jarl.emanuel.strange.02@regionh.dk",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":25,"geoPoint":25,"contacts":48},"Rigshospitalet Copenhagen University Hospital","RECRUITING","Copenhagen O","2100","Denmark","DK",[49,50,52],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":32,"role":51,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":53,"role":51,"phone":25,"phoneExt":25,"email":25},"Jesper Kjærgaard, Associate professor, DMSc, MD",{"type":51,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Emil Loldrup Fosbol","Professor","100565137","transcatheter-aortic-valve-implantation-in-aortic-stenosis-cardiogenic-shock-100565137",false,"NCT06638268","Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock","Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial","TACTICS","Inclusion Criteria:\n\n* Aortic valve area less than 1cm2\n\nAND\n\nCardiogenic Shock defined as:\n\n* Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol\u002Fl) AND\n* Systolic blood pressure \\\u003C 100 mmHg and\u002For need for vasopressor therapy (dopamine\u002F norepinephrine or epinephrine) AND\n* Left ventricular ejection fraction ≤ 45%\n\nOR\n\n\\- Syncope\u002Fresuscitation (mechanical ventilation)\n\nExclusion Criteria:\n\n* Intracranial hemorrhage \\\u003C 1 month ago\n* Remaining life-expectancy \\\u003C 6 month due to other cause\n* Body mass index \\\u003C15 OR \\> 40\n* Clinical frailty score ≥6 before present worsening\n* Severe lung disease (forced expiratory volume in 1 second OR diffusion capacity of the lungs for carbon monoxide \\\u003C 25 of expected)\n* Unsuitable for TAVI prior to screening","ALL",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis.\n\nThe main questions it aims to answer are:\n\n• Does acute TAVI increase survival compared with standard treatment?\n\nParticipants will:\n\n* Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission\n* Visit an outpatient clinic and be evaluated for quality of life and heart function",[74,75],"Aortic Stenosis","Cardiogenic Shock",[77,75,74,78,79,80,81,82,83],"Randomized Controlled Trial","Mortality","Frailty","Quality Of Life","Aortic Valve Stenosis","Transcatheter Aortic Valve Replacement","Transcatheter Aortic Valve Implantation","2026-04-17",{"date":86,"type":87},"2026-04-22","ACTUAL",{"date":89,"type":87},"2024-11-25",{"date":91,"type":68},"2027-10-30",{"name":5,"class":6},1]