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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07361055

Acronym

zeroPSVT

Enrollment

Registered

2026-01-22

Start date

2025-03-26

Completion date

2027-12-31

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardio Vascular Disease, Cryoablation

Keywords

zero-fluoroscopy, paroxysmal supraventricular tachycardia ablation

Brief 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

Interventions

DEVICEProtocol A

Mapping with DECANAV

DEVICEProtocol B

Mapping with NAVISTAR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The success of ablation	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

Measure	Time frame	Description
The complication rates	1Year	including the occurrence of AV block needing pacemaker, or pericardial effusion needing drainage, or use of fluoroscopy

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026