[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-refractory-paroxysmal-atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-refractory-paroxysmal-atrial-fibrillation":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28,29,30],"Atrial Fibrillation (AF)","Paroxysmal AF","Drug Refractory Paroxysmal Atrial Fibrillation","Atrial Arrhythmia","NOT_YET_RECRUITING","2026-07-19",{"date":34,"type":35},"2026-07-22","ACTUAL",{"date":37,"type":21},"2026-07-10",{"date":39,"type":21},"2028-11-30",{"name":41,"class":42},"Shanghai MicroPort EP MedTech Co., Ltd.","INDUSTRY","Drug-refractory Paroxysmal Atrial Fibrillation"]