[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580415":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":286,"collaborators":26,"id":288,"slug":289,"hasResults":290,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":290,"sex":296,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":26,"studyType":302,"phases":303,"briefSummary":305,"conditions":306,"keywords":311,"overallStatus":315,"whyStopped":26,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},{"fullName":5,"class":6},"The First Affiliated Hospital of Dalian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DS group","EXPERIMENTAL","The CA procedure will be performed under deep sedation in the study group mainly with propofol for sedation and fentanyl for analgesic",[13],"Procedure: deep sedation",{"label":15,"type":16,"description":17,"interventionNames":18},"CS group","SHAM_COMPARATOR","The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl.",[19],"Procedure: Conscious sedation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","deep sedation","The deep sedation was inducted using atropine 0.5 mg iv administered 15 min before the procedure to avoid aspiration. In the EP lab, anesthesia preparation is performed, including invasive arterial blood pressure monitoring via puncture of the radial artery or brachial artery. Noninvasive BP monitoring every 5 minutes is also permitted. Subsequently, midazolam 1-2mg or accompanied with propofol 0.3-0.5 mg\u002Fkg is administered intravenously at the start of the CA procedure (i.e., femoral vein puncture), and fentanyl 25 µg is administered intravenously. Then, continuous titrated infusion of propofol 0.2-0.5mg\u002Fkg\u002Fh for anesthesia maintenance throughout the CA procedure. An additional iv fentanyl (25-50 µg) is administrated at the beginning of RF applications. Further boluses or additional drugs are administrated as needed to maintain analgesia during the procedure. The anesthesiologist is responsible for administering anesthesia and administering medication.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conscious sedation","This protocol is aimed at analgesia, with local infiltration of lidocaine for femoral vein puncture followed by intravenous administration of fentanyl (1-2 ug\u002Fkg\u002Fh). The operator determines the dose of fentanyl and midazolam. A midazolam 1-5 mg bolus is administrated before electrical cardioversion is performed or when the patient is nervous.",[15],[32],{"name":33,"affiliation":5,"role":34},"Yunlong Xia, Ph.D","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+86 18098875555","yunlong_xia@126.com",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Chengming Ma, MD","+86 18098875759","machengming@dmu.edu.cn",[45,65,81,93,109,124,140,151,166,182,198,214,230,242,258,271],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Anhui Provincial Hospital","Hefei","Anhui","230036","China","CN",{"type":53,"coordinates":54},"Point",[55,56],117.28083,31.86389,{"lat":56,"lon":55},[59,63],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":62},"Hao Su","+86 13205517890","13330087693@wo.cn",{"name":64,"role":34,"phone":26,"phoneExt":26,"email":26},"Su Hao",{"facility":66,"status":26,"city":67,"state":68,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Guangdong Provincial People's Hospital","Guangzhou","Guangdong","510080",{"type":53,"coordinates":71},[72,73],113.25,23.11667,{"lat":73,"lon":72},[76,80],{"name":77,"role":37,"phone":78,"phoneExt":26,"email":79},"Yumei Xue","+86 13570082363","13570082363@139.com",{"name":77,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":82,"status":26,"city":67,"state":68,"zip":83,"country":50,"countryCode":51,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"NanFang Hospital","510515",{"type":53,"coordinates":85},[72,73],{"lat":73,"lon":72},[88,92],{"name":89,"role":37,"phone":90,"phoneExt":26,"email":91},"Yuegang Wang","+86 13725265686","13725265686@139.com",{"name":89,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":94,"status":26,"city":95,"state":96,"zip":97,"country":50,"countryCode":51,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Jiangsu Provincial Hospital","Nanjing","Jiangsu","210029",{"type":53,"coordinates":99},[100,101],118.77778,32.06167,{"lat":101,"lon":100},[104,108],{"name":105,"role":37,"phone":106,"phoneExt":26,"email":107},"Minglong Chen","+86 13809000791","13809000791@139.com",{"name":105,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":110,"status":26,"city":111,"state":96,"zip":112,"country":50,"countryCode":51,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"The First Affiliated Hospital of Soochow University","Suzhou","215006",{"type":53,"coordinates":114},[115,116],120.59538,31.30408,{"lat":116,"lon":115},[119,123],{"name":120,"role":37,"phone":121,"phoneExt":26,"email":122},"Tingbo Jiang","+86 18906201122","18906201122@189.com",{"name":120,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":125,"status":26,"city":126,"state":127,"zip":128,"country":50,"countryCode":51,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":53,"coordinates":130},[131,132],115.85306,28.68396,{"lat":132,"lon":131},[135,139],{"name":136,"role":37,"phone":137,"phoneExt":26,"email":138},"Ran Yin","+86 18679133150","18679133150@wo.cn",{"name":136,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":141,"status":26,"city":126,"state":127,"zip":142,"country":50,"countryCode":51,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"The Second Affiliated Hospital of Nanchang University","330008",{"type":53,"coordinates":144},[131,132],{"lat":132,"lon":131},[147,150],{"name":148,"role":37,"phone":149,"phoneExt":26,"email":62},"Qi Chen","+86 13330087693",{"name":148,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":152,"status":26,"city":153,"state":154,"zip":155,"country":50,"countryCode":51,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"First Affiliated Hospital of Dalian Medical University","Dalian","Liaoning","116011",{"type":53,"coordinates":157},[158,159],121.60222,38.91222,{"lat":159,"lon":158},[162],{"name":163,"role":37,"phone":164,"phoneExt":26,"email":165},"Xiaomeng Yin, Ph.D","+86 18098875778","dr.yinxm@163.com",{"facility":167,"status":26,"city":168,"state":169,"zip":170,"country":50,"countryCode":51,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Qingdao Municipal Hospital","Qingdao","Shandong","266011",{"type":53,"coordinates":172},[173,174],120.38042,36.06488,{"lat":174,"lon":173},[177,181],{"name":178,"role":37,"phone":179,"phoneExt":26,"email":180},"Bingong Li","+86 17669657168","17669657168@wo.cn",{"name":178,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":183,"status":26,"city":184,"state":185,"zip":186,"country":50,"countryCode":51,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Shanghai East Hospital","Shanghai","Shanghai Municipality","200120",{"type":53,"coordinates":188},[189,190],121.45806,31.22222,{"lat":190,"lon":189},[193,197],{"name":194,"role":37,"phone":195,"phoneExt":26,"email":196},"Zhigang Zhang","+86 18221885011","18221885011@139.com",{"name":194,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":199,"status":26,"city":200,"state":201,"zip":202,"country":50,"countryCode":51,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Shanxi Cardiovascular Hospital","Taiyuan","Shanxi","030001",{"type":53,"coordinates":204},[205,206],112.56028,37.86944,{"lat":206,"lon":205},[209,213],{"name":210,"role":37,"phone":211,"phoneExt":26,"email":212},"Haixiong Wang","+86 15003433600","15003433600@139.com",{"name":210,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":215,"status":26,"city":216,"state":217,"zip":218,"country":50,"countryCode":51,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Tianjin Chest Hospital","Tianjin","Tianjin Municipality","300010",{"type":53,"coordinates":220},[221,222],117.17667,39.14222,{"lat":222,"lon":221},[225,229],{"name":226,"role":37,"phone":227,"phoneExt":26,"email":228},"Fengmin Lu","+86 13902114455","13902114455@139.com",{"name":226,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":231,"status":26,"city":216,"state":217,"zip":232,"country":50,"countryCode":51,"cosmosGeoPoint":233,"geoPoint":235,"contacts":236},"Tianjin Medical University General Hospital","300050",{"type":53,"coordinates":234},[221,222],{"lat":222,"lon":221},[237,241],{"name":238,"role":37,"phone":239,"phoneExt":26,"email":240},"Heng Cai","+86 13821378394","caihengch@163.com",{"name":238,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":243,"status":26,"city":244,"state":245,"zip":246,"country":50,"countryCode":51,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"The Second Affiliated Hospital of Zhejiang University","Hangzhou","Zhejiang","310009",{"type":53,"coordinates":248},[249,250],120.16142,30.29365,{"lat":250,"lon":249},[253,257],{"name":254,"role":37,"phone":255,"phoneExt":26,"email":256},"Yaping Wang","+86 13805725837","wangypzju@163.com",{"name":254,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":259,"status":26,"city":244,"state":245,"zip":260,"country":50,"countryCode":51,"cosmosGeoPoint":261,"geoPoint":263,"contacts":264},"Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine","310016",{"type":53,"coordinates":262},[249,250],{"lat":250,"lon":249},[265,269],{"name":266,"role":37,"phone":267,"phoneExt":26,"email":268},"Sheng Xia","+86 13857158757","13857158757@139.com",{"name":270,"role":34,"phone":26,"phoneExt":26,"email":26},"Xia Sheng",{"facility":272,"status":26,"city":273,"state":245,"zip":274,"country":50,"countryCode":51,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"The Affiliated Hospital Of Medical School Of Ningbo University","Ningbo","315211",{"type":53,"coordinates":276},[277,278],121.54945,29.87819,{"lat":278,"lon":277},[281,285],{"name":282,"role":37,"phone":283,"phoneExt":26,"email":284},"Huimin Chu","+86 13566336742","markchu@126.com",{"name":282,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":287,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100580415","deep-sedation-in-catheter-ablation-of-atrial-fibrillation-100580415",false,"NCT06836999","Deep Sedation in Catheter Ablation of Atrial Fibrillation","Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation","PRIORI-AF","Inclusion Criteria:\n\n● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure\n\nExclusion Criteria:\n\n* has received CA procedure for AF or atrial septal defect repair before enrollment\n* left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;\n* eGFR\\\u003C30mL\u002Fmin\u002F1.73㎡\n* a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack \\[TIA\\])\n* acute or severe systemic infection\n* intolerant to sedation or with a history suggestive of sleep apnea\n* BMI \\> 35 kg\u002F㎡\n* has contraindications to procedural sedation or refused to participate in this trial\n* Congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio (INR) \\> 1.5 or partial activated prothrombin time (APTT) prolonged by ≥ 10 seconds, or plasma prothrombin time (PT) prolonged by ≥ 3 seconds, or fibrinogen (Fib) ≤ 1.5 g\u002FL), or active bleeding\n* pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period\n* life expectancy \\\u003C 12 months\n* those who have participated in other clinical drug trials within 3 months prior to enrollment\n* those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.\n* those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).","ALL","18 Years","75 Years",{"count":300,"type":301},1334,"ESTIMATED","INTERVENTIONAL",[304],"NA","The current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients\u002Fablators\u002Flab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients \u002F physicians \u002F lab staffs \u002F mapper clinical specialist experiences, and the procedure safety.",[307,308,309,310],"Atrial Fibrillation","Atrial Fibrillation, Paroxysmal or Persistent","Deep Sedations","Conscious Sedation",[23,312,313,314],"conscious sedation","catheter ablation","atrial fibrillation","NOT_YET_RECRUITING","2025-02-27",{"date":318,"type":319},"2025-03-04","ACTUAL",{"date":321,"type":301},"2025-03-03",{"date":323,"type":301},"2027-12-31",{"name":5,"class":6},16]