[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528182":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Hangzhou Dinova EP Technology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Focal pulse ablation system","EXPERIMENTAL",null,[13],"Device: Focal Pulse field Ablation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Focal Pulse field Ablation","Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Haitao Yang","CONTACT","+8637158680341","dinova_ep@dnaeps.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Fuwai Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":11,"email":44},"Ming Tang","+8613810665178","doctortangmin@sina.com",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100528182","an-exploratory-study-of-focal-pulse-ablation-system-in-the-treatment-of-atrial-arrhythmia-100528182",false,"NCT06157437","An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia","Inclusion Criteria:\n\n* Subjects aged at least 18;\n* Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;\n* Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.\n\nExclusion Criteria:\n\n* Any prior cavo-tricuspid isthmus ablation;\n* Unstable angina;\n* Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;\n* Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;\n* At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;\n* Implantable devices such as ICDs, CRTS and pacemakers in the body;\n* Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;\n* Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;\n* Previously received tricuspid metal valve replacement;\n* Thromboembolic events (including transient ischemic attacks) within the past 6 months;\n* Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;\n* Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;\n* Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;\n* Acute systemic infection;\n* Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;\n* Women who are pregnant or breastfeeding or who cannot use contraception during the study period;\n* Enrollment in another clinical trial evaluating other devices or drugs during the same period;\n* Life expectancy less than 12 months (e.g. advanced malignancy);\n* Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.","ALL","18 Years",{"count":56,"type":57},10,"ESTIMATED","INTERVENTIONAL",[60],"NA","This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.",[63,64],"Typical Atrial Flutter","Atrial Fibrillation (AF)","2025-02-07",{"date":67,"type":68},"2025-02-11","ACTUAL",{"date":70,"type":68},"2023-12-01",{"date":72,"type":57},"2025-06-30",{"name":5,"class":6},1]