A Comparison of Two Different Transseptal Puncture Strategies Without Fluoroscopy Guidance (TSP)

National Taiwan University

Status: Completed

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: 3D mapping system; Procedure: J Wire

Study type: Interventional

Funder types: Other

Identifiers

NCT07028502

202209049RIPA

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Echocardiography

Active Comparator group

Description:

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

Treatment:

Procedure: J Wire

3D mapping system

Experimental group

Description:

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.

Treatment:

Procedure: 3D mapping system