Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Research Title: Comparative study on the safety and effectiveness of AccuSafe transseptal guidewire versus traditional transseptal needle for transseptal puncture without X-ray guidance
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.
Study Design: Interventional clinical study
Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University from February 2025 to November 2025.
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.
Inclusion and Exclusion Criteria:
Inclusion Criteria: ①Age 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: ①History 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implantation; ② Intraoperative anatomical abnormalities requiring conversion to X-ray guidance-these patients will be withdrawn from the study and treated as dropouts.
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AccuSafe Transseptal Guidewire | Experimental | Patients undergo transseptal puncture using AccuSafe guidewire under ICE guidance without fluoroscopy. |
|
| Traditional Transseptal Needle | Active Comparator | Patients undergo transseptal puncture using conventional Brockenbrough needle under ICE guidance without fluoroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transseptal puncture needle | Device | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
①Age 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:
â‘ History of patent foramen ovale, atrial septal defect, post-atrial septal defect closure, post-valve replacement, or post-permanent pacemaker implantation; â‘¡ Intraoperative anatomical abnormalities requiring conversion to X-ray guidance-these patients will be withdrawn from the study and treated as dropouts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13649591 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided