AccuSafe guidewire vs traditional transseptal needle for X-ray-free transseptal puncture during AF ablation

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

This tests whether the AccuSafe transseptal guidewire is safer and more effective than the traditional transseptal needle for people with atrial fibrillation undergoing catheter ablation guided by intracardiac echocardiography without X-rays.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07515040 on ClinicalTrials.gov

What this trial studies

This randomized, single-center interventional trial will enroll 144 patients with atrial fibrillation scheduled for radiofrequency catheter ablation and randomize them 1:1 to transseptal puncture with the AccuSafe guidewire or a traditional transseptal needle. All procedures will be performed without fluoroscopy and guided by intracardiac echocardiography (ICE), with primary outcomes focused on procedural success and puncture-related complications. Safety endpoints include incidence of cardiac or vascular injury and need for conversion to X-ray guidance, while effectiveness endpoints include successful left atrial access and procedural workflow measures. Patients with abnormal fossa ovalis anatomy or prior septal repairs are excluded and intraoperative conversions to X-ray guidance will be treated as dropouts.

Who should consider this trial

Good fit: Adults aged 18–75 with diagnosed atrial fibrillation who are scheduled for radiofrequency catheter ablation and have normal fossa ovalis anatomy and can provide informed consent.

Not a fit: Patients with patent foramen ovale, atrial septal defects, prior septal closure, valve replacement, permanent pacemaker implantation, or those who require conversion to X‑ray guidance are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the AccuSafe guidewire approach could reduce X-ray exposure and lower puncture-related complications, improving safety and procedural success for AF ablation patients.

How similar studies have performed: ICE-guided, X-ray-free transseptal techniques and dedicated guidewires have shown promising safety in small series, but randomized comparisons specifically of AccuSafe versus traditional needles are limited.

Eligibility 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.

Where this trial is running

Nanchang, Jiangxi

• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)

Conditions: Atrial Fibrillation