NCT07028502

A Comparison of Two Different Transseptal Puncture Strategies Without Fluoroscopy Guidance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Zero-fluoroscopy is the dream of all interventionists, and as low as reasonably achievable (ALARA) is the goal the investigators can manage at this moment. Trans-septal puncture (TSP) is the most pivotal step in the ablation procedure for left heart procedure, including atrial fibrillation ablation, and it is the only step that still needs fluoroscopy in the era of 3D electroanatomical map. With the incorporation of intracardiac echocardiography (ICE), the dream of zerofluoroscopy can be achieved. Because the imaging offered by fluoroscopy or ICE is so different in terms of the advantages and shortages, the best TSP protocols might be different. Currently, in the literature, two techniques are commonly referred. However, no comparison has been made between these two techniques. Therefore, this study is to compare the safety and efficiency of these two techniques, also to observe the transition of a senior EP doctor who has been experienced in fluoroscopy-guided TSP, hoping to establish the learning curve for future reference of zerofluoroscopy promotion.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	J Wire	The movement of the puncture needle was monitored using intracardiac echocardiography rather than fluoroscopy. All other steps followed the conventional approach.
PROCEDURE	3D mapping system	Guided by the ablation catheter image on the 3D mapping system, the long sheath was advanced to the puncture site and then exchanged for a puncture needle. The entire procedure was monitored with intracardiac echocardiography.

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2025-06-19
• Last updated: 2026-01-16

Locations

1 site across 1 country: Taiwan