Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias (ZFOVA)

Tongji Hospital

Status: Unknown

Conditions: Ventricular Arrythmia; Ventricular Premature Complexes; Ventricular Tachycardia

Treatments: Procedure: Zero-fluoroscopy ablation; Procedure: Conventional fluoroscopy ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03041519

TJHXXG-ZF-VT-20161220

Details and patient eligibility

About

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

Full description

Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ventricular Tachycardia
• Ventricular Premature Complexes

Exclusion criteria

• Organic ventricular tachycardia or ventricular premature complexes
• Drug-induced ventricular tachycardia or ventricular premature complexes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Zero-fluoroscopy ablation

Experimental group

Description:

Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure.

Treatment:

Procedure: Zero-fluoroscopy ablation

Conventional fluoroscopy ablation

Active Comparator group

Description:

Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.

Treatment:

Procedure: Conventional fluoroscopy ablation