[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595716":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Shanghai MicroPort EP MedTech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-centre, post-marketing study","EXPERIMENTAL","This study aims to evaluate the safety and efficacy of using a domestically produced cardiac cryoablation system to treat paroxysmal atrial fibrillation.",[13],"Device: IceMagic™ CryoAblation Catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","IceMagic™ CryoAblation Catheter","IceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kaijun K Cui, PhD","CONTACT","028-60660000","hxjj@cd120.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":36,"coordinates":37},"Point",[38,39],104.06667,30.66667,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":47,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Gao Henggan","Cui Kaijun","West China Hospital","100595716","a-clinical-study-on-the-use-of-a-domestically-produced-cryoablation-system-combined-with-balloon-cryoablation-technology-for-the-treatment-of-paroxysmal-atrial-fibrillation-100595716",false,"NCT07036068","A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation","Balloon cryoab","Inclusion Criteria:\n\n1. Patient age between 18 and 80 years old, male or non-pregnant female.\n2. Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery.\n3. Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.\n\nExclusion Criteria:\n\n1. Patients who have undergone atrial fibrillation ablation surgery\n2. Reproductive-age patients who cannot use effective contraception within 12 months of enrolment\n3. Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%\n4. Left atrial thrombus\n5. Patients who have undergone atrial septal defect repair surgery or atrial myxoma\n6. Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)\n7. 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)\n8. Patients with acute or severe systemic infection\n9. Patients with severe liver or kidney disease\n10. Patients with a significant tendency to bleed or haematological disorders\n11. Patients with malignant tumours or end-stage diseases\n12. Patients deemed ineligible for this trial by the investigator","ALL","18 Years","80 Years",{"count":59,"type":60},20,"ESTIMATED","INTERVENTIONAL",[63],"NA","To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.",[66],"Paroxysmal Atrial Fibrillation (PAF)",[68,69,70],"PFA","PeAF","PFA\u002FRF","NOT_YET_RECRUITING","2025-06-26",{"date":74,"type":75},"2025-06-27","ACTUAL",{"date":77,"type":60},"2025-08-31",{"date":79,"type":60},"2027-12-31",{"name":5,"class":6},1]