[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648224":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":40,"collaborators":20,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":20,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":20,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Shanghai MicroPort EP MedTech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PulseMagic™ TrueForce™ Ablation catheter","EXPERIMENTAL","A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.",[13],"Device: PFA Ablation catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","PFA Ablation catheter","Deliver PF energy using the PulseMagic™ PFA system",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yan Yao","CONTACT","010-88392405","ianyao@263.net.cn",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":20},"Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","Beijing Municipality","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},{"type":41,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100648224","pulsemagic-trueforce-paf-nmpa-study-100648224",false,"NCT07720557","PulseMagic™ TrueForce™ PAF NMPA Study","A Study of Pulsed Field Ablation With the PulseMagic™ TrueForce™ Catheter and PulseMagic™ PFA Generator for the Treatment of Paroxysmal Atrial Fibrillation (PFATrueForce)","PFATrueForce","Inclusion Criteria:\n\n* Aged ≥ 18 years old.\n* Clinically diagnosed with symptomatic paroxysmal atrial fibrillation.\n* Atrial fibrillation documented by surface electrocardiogram (ECG), or ambulatory electrocardiogram (including single-lead ECG recorder).\n* Poor response or intolerance to at least one Class I or Class III antiarrhythmic drug.\n* Fully informed of the treatment regimen, voluntarily signed the informed consent form, and agreed to undergo all examinations, procedures and follow-up visits specified in the study protocol.\n\nExclusion Criteria:\n\n* Patients with a history of atrial fibrillation ablation.\n* Left atrial thrombus.\n* Left atrial anteroposterior diameter ≥ 60 mm, and left ventricular ejection fraction (LVEF) ≤ 40%.\n* Patients with active implantable devices in situ (e.g., cardiac pacemaker, ICD, etc.).\n* Women of childbearing potential who cannot use effective contraception throughout the 12-month study period after enrollment.\n* Atrial fibrillation caused by hyperthyroidism or other transient factors.\n* Patients with prior atrial septal repair, atrial septal occlusion, or left atrial myxoma.\n* Patients with confirmed cerebrovascular diseases within the past 6 months (including cerebral hemorrhage, stroke and transient ischaemic attack).\n* Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention, coronary artery bypass grafting, prosthetic valve replacement or repair, atrial or ventricular incision).\n* Patients deemed ineligible for this trial by the investigator for any other reason.","ALL","18 Years",{"count":53,"type":54},150,"ESTIMATED","INTERVENTIONAL",[57],"NA","This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with Pulsed Field Ablation Software for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).",[60,61,62,63],"Atrial Fibrillation (AF)","Paroxysmal AF","Drug Refractory Paroxysmal Atrial Fibrillation","Atrial Arrhythmia","NOT_YET_RECRUITING","2026-07-19",{"date":67,"type":68},"2026-07-22","ACTUAL",{"date":70,"type":54},"2026-07-10",{"date":72,"type":54},"2028-11-30",{"name":5,"class":6},1]