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Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance

RecruitingNAAges 18 Years - 75 YearsAllSecond Affiliated Hospital of Nanchang University
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In plain words

What the trial is, and whether it could suit you

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 2. 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. 3. Study Design: Interventional clinical study 4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University from February 2025 to November 2025. 5. Sample Size: N=144 patients, randomly a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: โ‘  Age 18-75 years (inclusive); โ‘ก Clinically diagnosed with atrial fibrillation, indicated for radiofrequency ablation, and scheduled for catheter ablation; โ‘ข Voluntarily agrees to participate in the trial and has signed informed consent; โ‘ค 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: โ‘  History of patent foramen ovale, atrial septal defect, post-atrial septal defect closure, post-valve replacement, or post-permanent pacemaker implantation; โ‘ก Intraoperative anatomical abnormalities requiring conversion to X-ray guidance-these patients will be withdrawn from the study and treated as dropouts.
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What it tests

  • Transseptal puncture needle
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Where

1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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