[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632542":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":23,"interventions":35,"overallOfficials":16,"centralContacts":16,"locations":41,"responsibleParty":62,"collaborators":16,"id":64,"slug":16,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":16,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":16,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":44,"whyStopped":16,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Second Affiliated Hospital of Nanchang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"First-pass success rate of transseptal puncture","Defined as successful access to the left atrium on the first attempt during transseptal puncture.","During procedure",{"measure":14,"description":15,"timeFrame":12},"transseptal puncture procedure time","The time elapsed from the initial contact of the atrial septal puncture device (puncture needle or guidewire) with the atrial septum until a stable left atrial access is successfully established",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"AccuSafe Transseptal Guidewire","EXPERIMENTAL","Patients undergo transseptal puncture using AccuSafe guidewire under ICE guidance without fluoroscopy.",[29],"Device: Transseptal puncture needle",{"label":31,"type":32,"description":33,"interventionNames":34},"Traditional Transseptal Needle","ACTIVE_COMPARATOR","Patients undergo transseptal puncture using conventional Brockenbrough needle under ICE guidance without fluoroscopy.",[29],[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":16},"DEVICE","Transseptal puncture needle","The Accusafe atrial septal puncture guidewire combines puncture and guidance functions. Its structure primarily consists of a J-shaped tip, a nickel-titanium alloy shaft, a radiopaque coil, and positioning markers. Because the guidewire itself possesses strong puncture capabilities, it can typically pass through complex anatomical conditions-such as fibrotic or thickened foramen ovale or atrial septal aneurysms-relatively smoothly, offering distinct advantages in difficult puncture scenarios.",[25,31],[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Second Affiliated Hospital of Nanchang University","RECRUITING","Nanchang","Jiangxi","330006","China","CN",{"type":51,"coordinates":52},"Point",[53,54],115.85306,28.68396,{"lat":54,"lon":53},[57],{"name":58,"role":59,"phone":60,"phoneExt":16,"email":61},"Qi Chen","CONTACT","+86 13330087693","efycq@189.cn",{"type":63,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100632542",false,"NCT07515040","Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance","Inclusion Criteria:\n\n① Age 18-75 years (inclusive); ② Clinically diagnosed with atrial fibrillation, indicated for radiofrequency ablation, and scheduled for catheter ablation; ③ Voluntarily agrees to participate in the trial and has signed informed consent; ⑤ Willing to comply with the trial requirements and complete the required follow-up. (All patients must have normal fossa ovalis anatomy confirmed by preoperative echocardiography; complex cases such as patent foramen ovale and atrial septal aneurysm are excluded)\n\nExclusion Criteria:\n\n① History of patent foramen ovale, atrial septal defect, post-atrial septal defect closure, post-valve replacement, or post-permanent pacemaker implantation; ② Intraoperative anatomical abnormalities requiring conversion to X-ray guidance-these patients will be withdrawn from the study and treated as dropouts.",true,"ALL","18 Years","75 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"NA","1. Research Title: Comparative study on the safety and effectiveness of AccuSafe transseptal guidewire versus traditional transseptal needle for transseptal puncture without X-ray guidance\n2. Research Objective: This study aims to compare the safety and effectiveness of the AccuSafe guidewire with the traditional transseptal needle in performing X-ray-free transseptal puncture under ICE guidance. Through this study, we hope to provide a safer and more effective method for transseptal puncture, reduce X-ray exposure for both patients and physicians, improve surgical success rates, and decrease the incidence of complications.\n3. Study Design: Interventional clinical study\n4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University from February 2025 to November 2025.\n5. Sample Size: N=144 patients, randomly assigned using a computer-generated random number table to the AccuSafe guidewire group (n=72) or the traditional TSP needle group (n=72) at a 1:1 ratio.\n6. Inclusion and Exclusion Criteria:\n\n   Inclusion Criteria: ① Age 18-75 years (inclusive); ② Clinically diagnosed with atrial fibrillation, indicated for radiofrequency ablation, and scheduled for catheter ablation; ③ Voluntarily agrees to participate in the trial and has signed informed consent; ⑤ Willing to comply with the trial requirements and complete the required follow-up. (All patients must have normal fossa ovalis anatomy confirmed by preoperative echocardiography; complex cases such as patent foramen ovale and atrial septal aneurysm are excluded.) Exclusion Criteria: ① History of patent foramen ovale, atrial septal defect, post-atrial septal defect closure, post-valve replacement, or post-permanent pacemaker implantation; ② Intraoperative anatomical abnormalities requiring conversion to X-ray guidance-these patients will be withdrawn from the study and treated as dropouts.\n7. Observational Indicators:(1) Baseline Data: Age, sex, BMI, type of atrial fibrillation, CHA2DS2-VASc score, left atrial diameter, ejection fraction, and the proportion of patients with diabetes, hypertension, congestive heart failure, stroke\u002FTIA, and coronary artery disease.(2) Surgical Data: First puncture success rate, surgical complications, total procedure time, X-ray exposure, total TSP time, number of punctures required to achieve left atrial access, and width of atrial septal shunt at the end of ablation.\n8. Statistical Analysis: Data will be analyzed using IBM SPSS Statistics 27.0. Normally distributed measurement data will be expressed as mean ± standard deviation, and comparisons between two independent samples will be performed using t-tests. Categorical data will be expressed as frequency and percentage, with comparisons conducted using the chi-square test. Two-sided P\\\u003C0.05 will be considered statistically significant.",[81],"Atrial Fibrillation (AF)",[83],"Atrial Fibrillation","2026-03-31",{"date":86,"type":87},"2026-04-07","ACTUAL",{"date":89,"type":87},"2025-02-26",{"date":91,"type":75},"2027-02-26",{"name":5,"class":6},1]