NCT07361055

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cardio Vascular Disease
• Cryoablation

Interventions

Type	Name	Description
DEVICE	Protocol A	Mapping with DECANAV
DEVICE	Protocol B	Mapping with NAVISTAR

Timeline

• Start date: 2025-03-26
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: Taiwan