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OpenTrials
Enrolling by Invitation

NCT Number: NCT07361055

The Best Workflow for Paroxysmal Supraventricular Tachycardia Ablation With Zero-fluoroscopy

Primary Objective: To observe, record, and analyze the workflow and guidance system efficiency of these two surgical procedures, including placement time, location, and the number of successful placements.

Secondary Objective: To compare the differences between the two procedures and observe and record the process of transitioning to intracardiac ultrasound guidance by experienced physicians performing both workflows. The primary focus is on the time spent on target steps and related complications, with the aim of reducing radiation exposure during the procedure with the new technology.

Enrolling by Invitation

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Key information

Conditions

Cardio Vascular Disease Cryoablation

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

About this study

The aim of this study is to compare the safety and efficiency of two workflows (with or without FAM Dx) using CARTO® 3 System for PSVT ablation. The results will later be compared with another 3-dimentional mapping system (Ensite™) historically

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with documented PSVT on ECG. Twelve-lead is preferred. Single-lead is acceptable if recording quality is good enough for interpretation.
  • Patients who are willing to sign the informed consent.

Exclusion criteria

  • The patients had received PSVT ablation procedure before.
  • Informed consent could not be obtained

Treatment and study plan

Protocol A

Device

Mapping with DECANAV

Other names: FAM DX+, DECANAV®

Protocol B

Device

Mapping with NAVISTAR

Other names: FAM DX-, NAVISTAR®

Primary outcomes

  1. The success of ablation

    Time frame: 1Year

    defined by elimination of accessory pathway and slow nodal pathway or modification of the slow nodal pathway with which a PSVT upto 3 reentrants would not be induced

Secondary outcomes

  1. The complication rates

    Time frame: 1Year

    including the occurrence of AV block needing pacemaker, or pericardial effusion needing drainage, or use of fluoroscopy

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Johnson & Johnson

Registry information

Acronym: zeroPSVT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 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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