Clinical Trial

A Comparison of Two Different Transseptal Puncture Strategies Without Fluoroscopy Guidance

Study acronym: TSP
Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-17.
Trial Details
NCT Number NCT07028502
Lead Sponsor National Taiwan University Hospital
Conditions Atrial Fibrillation (AF)
Enrollment 28 participants
Start Date 2023-04-20
Primary Completion 2024-06-30 (estimated)
Study Completion 2024-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-16