The Best Workflow for Paroxysmal Supraventricular Tachycardia Ablation With Zero-fluoroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protocol A, Protocol B.
- Who it may be relevant to
- Registry conditions: Cardio Vascular Disease, Cryoablation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device Protocol A
Mapping with DECANAV - Device Protocol B
Mapping with NAVISTAR
Primary outcome measures
- The success of ablation [Time frame: 1Year]
Secondary outcome measures (1)
- The complication rates [Time frame: 1Year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospita — Taipei
Identifiers
NCT: NCT07361055 · 202401199RIPB