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

National Taiwan University

Status: Invitation-only

Conditions: Cardio Vascular Disease; Cryoablation

Treatments: Device: Protocol A; Device: Protocol B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07361055

202401199RIPB

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. The patients had received PSVT ablation procedure before.
2. 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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70 participants in 2 patient groups

Protocol A (Fam DX+)

Experimental group

Description:

Create geometry FAM Mapping with DECANAV(Fam DX+)

Treatment:

Device: Protocol A

Protocol B (FAM DX-)

Active Comparator group

Description:

Create geometry FAM MAPPING WITH NAVISTAR (FAM DX-)

Treatment:

Device: Protocol B