[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649341":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":33,"collaborators":10,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":10,"enrollmentInfo":44,"targetDuration":10,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":10,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort 1",null,"Sedation will be carried by remimazolam (Paion Pharma, Aachen, Germany), and bolus doses of fentanyl will be used as an analgesic agent. At the beginning of the anesthesiologic procedures, the patients will receive an intravenous dose of 50 µg fentanyl followed by a bolus dose of remimazolam 5 mg (patients younger than 65 years with a weight over 50 kg), or remimazolam 2.5-5 mg (patients with age \\> 65 years or ASA classification III-IV). The sedation will continue by intravenous infusion of remimazolam 0.5 mg\u002Fkg\u002Fh. Before the start of pulses, sedation\u002Fanalgesia will be strengthened by bolus application of remimazolam 1,25-2.5 mg, and fentanyl 50-100 ug, respectively. At the same time, magnesium sulphate 1 g will be applied by a slow infusion. Additional doses of remimazolam\u002Ffentanyl could be administered and recorded in study protocols.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Marek Hozman, MD, PhD","CONTACT","+420267 161 111","marek.hozman@fnkv.cz",[19],{"facility":20,"status":21,"city":22,"state":10,"zip":23,"country":24,"countryCode":10,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"University Hospital Kralovske Vinohrady","RECRUITING","Prague","100000","Czechia",{"type":26,"coordinates":27},"Point",[28,29],14.42076,50.08804,{"lat":29,"lon":28},[32],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"type":34,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649341","remimazolam-fentanyl-mild-conscious-sedation-regimen-in-pulsed-field-ablation-for-paroxysmal-atrial-fibrillation-100649341",false,"NCT07734194","Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation","ReFeR-PFA","Inclusion Criteria:\n\nAge above 18y Paroxysmal or persistent AF written agreement with inclusion to the study\n\nExclusion Criteria:\n\nBMI \\> 35kg\u002Fm2 EF of the left ventricle \\\u003C 40% OSA syndrome on therapy anticipated difficult airway severe COPD significant valvulopathy (3\u002F4 or more) symptomatic heart failure irrespective of ejection fraction severe pulmonary hypertension benzodiazepine drugs medication (or other sedative drugs at the discretion of the anesthesiologist) myasthenia gravis","ALL","18 Years",{"count":45,"type":46},20,"ESTIMATED","OBSERVATIONAL","This prospective single-arm study will evaluate whether mild conscious sedation using remimazolam with fentanyl is a feasible alternative to deeper sedation or general anaesthesia during FARAPULSETM pulsed-field ablation for paroxysmal atrial fibrillation, with careful periprocedural monitoring and assessment of both sedation-related safety outcomes and patient-reported procedural experience.",[50],"Atrial Fibrillation (AF)","2026-07-24",{"date":53,"type":54},"2026-07-29","ACTUAL",{"date":56,"type":54},"2026-01-01",{"date":58,"type":46},"2026-08-01",{"name":5,"class":6},1]