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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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 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.
6. Inclusion and Exclusion Criteria:

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.
7. 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/TIA, 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.
8. 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\<0.05 will be considered statistically significant.

Eligibility

Primary outcome measure(s)

• First-pass success rate of transseptal puncture — During procedure
  Defined as successful access to the left atrium on the first attempt during transseptal puncture.
• transseptal puncture procedure time — During procedure
  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

Trial sites (1)

More Second Affiliated Hospital of Nanchang University trials in China

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