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

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implantation; ② Intraoperative anatomical abnormalities requiring conversion to X-ray guidance-these patients will be withdrawn from the study and treated as dropouts.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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Device: Transseptal puncture needle

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Qi Chen; Phone Number: +86 13330087693; Email: efycq@189.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AccuSafe Transseptal Guidewire; Patients undergo transseptal puncture using AccuSafe guidewire under ICE guidance without fluoroscopy.	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.
Active Comparator: Traditional Transseptal Needle; Patients undergo transseptal puncture using conventional Brockenbrough needle under ICE guidance without fluoroscopy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-pass success rate of transseptal puncture	Defined as successful access to the left atrium on the first attempt during transseptal puncture.	During procedure
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	During procedure

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Publications and helpful links

General Publications

• ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: I-2025095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No