NCT07028502

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

April 27, 2025

Last Update Submit

January 15, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

AblationTrans-septal puncture (TSP)Zero-fluoroscopyAtrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • Total TSP time

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

    Perioperative

  • Fluoroscopy usage and radiation dose

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

    during the procedure

  • Incidence of procedural complications

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

    up to 12 weeks

Study Arms (2)

Echocardiography

ACTIVE COMPARATOR

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

Procedure: J Wire

3D mapping system

EXPERIMENTAL

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.

Procedure: 3D mapping system

Interventions

3D mapping systemPROCEDURE

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.

Also known as: Vizigo set
3D mapping system
J WirePROCEDURE

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

Echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospita

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2025

First Posted

June 19, 2025

Study Start

April 20, 2023

Primary Completion

June 30, 2024

Study Completion

September 30, 2024

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)