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OpenTrials
Completed

NCT Number: NCT07028502

A Comparison of Two Different Transseptal Puncture Strategies Without Fluoroscopy Guidance

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospita

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

J Wire

Procedure

The movement of the puncture needle was monitored using intracardiac echocardiography rather than fluoroscopy. All other steps followed the conventional approach.

3D mapping system

Procedure

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.

Other names: Vizigo set

Primary outcomes

  1. Total TSP time

    Time frame: Perioperative

    Time duration from femoral venous access to the completion of both the first and second transseptal puncture (TSP).

    Unit of Measure: Minutes

  2. Fluoroscopy usage and radiation dose

    Time frame: during the procedure

    Whether fluoroscopy was used during the procedure and the corresponding radiation dose recorded if applicable.

  3. Incidence of procedural complications

    Time frame: up to 12 weeks

    Occurrence of major complications during the procedure, including pericardial effusion, cardiac tamponade, stroke, or death.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Acronym: TSP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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