[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636881":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":11,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Gødstrup Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardiologist-only (intervention)","EXPERIMENTAL",null,[13],"Other: One-step cardiologist-only midazolam sedation",{"label":15,"type":16,"description":11,"interventionNames":17},"With anaesthesiology assistance (standard care)","ACTIVE_COMPARATOR",[18],"Other: Two-step anaesthesiologist-assisted propofol sedation",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"One-step cardiologist-only midazolam sedation","TOE-guided DCC performed under continuous cardiologist-administered midazolam sedation, without anaesthesiologist involvement.\n\nMidazolam is administered intravenously at the discretion of the treating cardiologist.\n\nNon-binding dosing guidance is provided to support clinical practice, but dosing may be individualised as clinically indicated.\n\n* For the TOE phase, suggested dosing includes an initial IV dose of 1.25-5.0 mg, with repeat doses of 1.25-2.5 mg as needed, and a suggested maximum cumulative dose of 20 mg.\n* For the DCC phase, suggested dosing includes an initial IV dose of 2.5-7.5 mg, with repeat doses of 2.5 mg as needed. A suggested maximum cumulative dose of 25 mg applies, including doses administered during the TOE phase.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Two-step anaesthesiologist-assisted propofol sedation","TOE performed under cardiologist-administered sedation followed by a wake-up period and subsequent DCC performed under propofol sedation administered by an anaesthesiologist.\n\nSedation for TOE and DCC is administered following established local guidelines.",[15],[29,50],{"facility":5,"status":11,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Herning","Central Jutland","7400","Denmark","DK",{"type":36,"coordinates":37},"Point",[38,39],8.97662,56.13615,{"lat":39,"lon":38},[42,47],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Usama Sikandar, MD, PhD Student","CONTACT","+45 51 43 18 08","usama.sikandar@rm.dk",{"name":48,"role":44,"phone":11,"phoneExt":11,"email":49},"Morten Schmidt, MD, PhD, DMSc, MSc (Oxon)","morsch@rm.dk",{"facility":51,"status":11,"city":52,"state":31,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Randers Regional Hospital","Randers",{"type":36,"coordinates":54},[55,56],10.03639,56.4607,{"lat":56,"lon":55},[59,63],{"name":60,"role":44,"phone":61,"phoneExt":11,"email":62},"Kasper Glerup Lauridsen, MD, PhD","+45 78 42 17 70","kglerup@clin.au.dk",{"name":64,"role":44,"phone":11,"phoneExt":11,"email":65},"Bo Løfgren, MD, PhD, FESC, FAHA","bl@clin.au.dk",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[69],{"name":70,"class":6},"University of Aarhus","100636881","phase-4-cardiologist-administered-midazolam-vs-anaesthesiologist-assisted-propofol-sedation-for-transoesophageal-echocardiography-guided-cardioversion-of-atrial-fibrillation-100636881",false,"NCT07571447","Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial Fibrillation","Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial Fibrillation (CARDIOZOLAM-1)","CARDIOZOLAM-1","Inclusion Criteria:\n\n* Adult patients (≥18 years) with atrial fibrillation or flutter\n* Scheduled for transoesophageal echocardiography-guided direct current cardioversion\n\nExclusion Criteria:\n\n1. Previous enrolment in the trial\n2. Expected prolonged hospitalisation (\\>8 hours) despite sinus rhythm restoration:\n\n   * Ongoing medical needs after cardioversion (e.g., decompensation or infection)\n   * Planned procedures after cardioversion (same-day TTE or pacemaker test allowed)\n   * Social barriers for same-day discharge\n3. Indication for anaesthesiology assistance:\n\n   * Haemodynamic instability (systolic blood pressure \\\u003C90 mmHg)\n   * Known severe pulmonary disease (FVC or FEV1 \\\u003C50% predicted)\n   * Body mass index \\>40 kg\u002Fm2\n   * Previous complications or allergic reactions to sedation\n4. Contraindications:\n\n   * Pregnant or breastfeeding\n   * Intracardiac thrombus\n   * Total benzodiazepine dose used for TOE \\>20 mg\n\nAbbreviations: FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography.","ALL","18 Years",{"count":82,"type":83},220,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Irregular heart rhythms, known as atrial fibrillation or atrial flutter, are common conditions that can increase the risk of stroke and heart failure. A standard treatment to restore a normal rhythm is a controlled electric shock, known as cardioversion. However, if the irregular rhythm has lasted more than 24 hours, if the duration is uncertain, and if the patient has not been on blood-thinning medication for at least three weeks, doctors must first check for blood clots in the heart. This is done using a special ultrasound scan of the heart through the food pipe.\n\nBoth the scan and the electric shock treatment require sedation to make the patient relaxed or asleep. The scan uses mild sedation from a cardiologist, while the shock needs a stronger sedative given by an anaesthesiologist. But needing this extra doctor can cause delays, so patients often wait longer for treatment and to go home.\n\nThis study will test whether a cardiologist can safely handle both steps using a sedative called midazolam. This study will include 220 adults at multiple hospitals in Denmark and compare this new approach to standard care. Researchers will track how quickly patients go home, how well the treatment works, any serious side effects, what patients think about the experience, and how much money can be saved.\n\nIf proven safe and effective, this new method could reduce treatment delays, shorten hospital stays, and lower healthcare costs-ultimately improving care for patients and making the healthcare system more efficient.",[89,90],"Atrial Fibrillation (AF)","Atrial Flutter",[92,93],"Direct current cardioversion","Transoesophageal echocardiography","NOT_YET_RECRUITING","2026-04-30",{"date":97,"type":98},"2026-05-06","ACTUAL",{"date":100,"type":83},"2026-05",{"date":102,"type":83},"2027-05",{"name":5,"class":6},2]