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NCT07028502Completed

A Comparison of Two Different Transseptal Puncture Strategies Without Fluoroscopy Guidance

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
28 (actual)
First submitted
27 Apr 2025
Start date
20 Apr 2023
Primary completion date
30 Jun 2024
Lead sponsor
National Taiwan University Hospital
NCT number
NCT07028502

What you commit to

  • Study type: Interventional
  • Participants enrolled: 28
  • From 20 Apr 2023 to the primary completion date, 30 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • The patients need right atrial mapping and/or ablation before TSP.
  • The women who is pregnant.
  • Informed consent could not be obtained.

Who the study is looking for

  • Patients with paroxysmal or persistent AF and are scheduled to undergo at least but not limited to pulmonary vein (PV) isolation.
  • Patients who are willing to sign the informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Taiwan University Hospita
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.