An interventional study of Protocol A and Protocol B in Cardio Vascular Disease and Cryoablation, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Create geometry FAM Mapping with DECANAV(Fam DX+)
Device: Protocol A
Create geometry FAM MAPPING WITH NAVISTAR (FAM DX-)
Device: Protocol B
Mapping with DECANAV
Also known as: FAM DX+, DECANAV®
Mapping with NAVISTAR
Also known as: FAM DX-, NAVISTAR®
The success of ablation
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
Time frame: 1Year
The complication rates
including the occurrence of AV block needing pacemaker, or pericardial effusion needing drainage, or use of fluoroscopy
Time frame: 1Year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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National Taiwan University Hospital