[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595476":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":22,"slug":23,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":26,"acronym":11,"eligibilityCriteria":27,"healthyVolunteers":24,"sex":28,"minAge":29,"maxAge":30,"enrollmentInfo":31,"targetDuration":11,"studyType":34,"phases":35,"briefSummary":37,"conditions":38,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":50,"locationsCount":11},{"fullName":5,"class":6},"Shanghai MicroPort EP MedTech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation）","EXPERIMENTAL",null,[13],"Device: FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System","All patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia.",[9],{"type":21,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100595476","safety-and-efficacy-study-of-the-first-domestically-produced-firemagic-precisense-3d-microelectrode-ablation-catheter-therapy-for-rapid-arrhythmia-with-tissue-temperature-measurement-function-100595476",false,"NCT07032948","Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function","1\\. Inclusion Criteria\n\n1. Patient age between 18 and 75 years old, male or non-pregnant female;\n2. Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;\n3. Signed informed consent form approved by the ethics committee;\n4. Willingness to undergo follow-up and evaluation as required by the protocol.\n\n2\\. Exclusion Criteria Include:\n\n1. Exclusion criteria for atrial fibrillation patients:\n\n   Patients should not participate in this study if any of the following conditions apply:\n   * Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%;\n   * Left atrial thrombus;\n   * History of atrial septal repair or atrial myxoma;\n   * History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);\n   * Cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);\n   * Acute or severe systemic infection;\n   * Severe liver or kidney disease;\n   * Significant bleeding tendency or haematological disorders;\n   * Patients with other conditions deemed inappropriate for participation in this trial by the investigators.\n2. Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:\n\nPatients should not participate in this study if any of the following conditions apply:\n\n* Left atrial size ≥50 mm and left ventricular ejection fraction ≤40%;\n* History of atrial septal defect repair or atrial myxoma;\n* Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);\n* Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);\n* Patients with acute or severe systemic infection;\n* Patients with severe liver or kidney disease;\n* Patients with a significant tendency to bleed or haematological disorders;\n* Patients with other conditions deemed by the investigator to be unsuitable for participation in this trial.","ALL","18 Years","75 Years",{"count":32,"type":33},300,"ESTIMATED","INTERVENTIONAL",[36],"NA","This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.",[39,40,41],"Rapid Arrhythmia","Atrial Fibrillation (AF)","Paroxysmal Supraventricular Tachycardia (PSVT)","NOT_YET_RECRUITING","2025-06-23",{"date":45,"type":46},"2025-06-24","ACTUAL",{"date":48,"type":33},"2025-08-31",{"date":48,"type":33},{"name":5,"class":6}]