[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":29,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Second Affiliated Hospital of Nanchang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AccuSafe Transseptal Guidewire","EXPERIMENTAL","Patients undergo transseptal puncture using AccuSafe guidewire under ICE guidance without fluoroscopy.",[13],"Device: Transseptal puncture needle",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Transseptal Needle","ACTIVE_COMPARATOR","Patients undergo transseptal puncture using conventional Brockenbrough needle under ICE guidance without fluoroscopy.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9,15],null,[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Second Affiliated Hospital of Nanchang University","RECRUITING","Nanchang","Jiangxi","330006","China","CN",{"type":36,"coordinates":37},"Point",[38,39],115.85306,28.68396,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Qi Chen","CONTACT","+86 13330087693","efycq@189.cn",{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100632542","comparative-study-on-the-safety-and-efficacy-of-using-accusafe-transseptal-guidewire-versus-traditional-transseptal-needle-for-transseptal-puncture-in-non-or-free--guidance-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":60,"type":61},80,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67],"Atrial Fibrillation (AF)",[69],"Atrial Fibrillation","2026-03-31",{"date":72,"type":73},"2026-04-07","ACTUAL",{"date":75,"type":73},"2025-02-26",{"date":77,"type":61},"2027-02-26",{"name":5,"class":6},1]