Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia (ZFA-PSVT)

Tongji Hospital

Status: Completed

Conditions: Paroxysmal Supraventricular Tachycardia

Treatments: Device: Zero-fluoroscopic ablation; Device: Conventional fluoroscopic ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03042078

TJHCDD-ZF-PSVT-20140301

Details and patient eligibility

About

This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Full description

Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Enrollment: 3,060 patients

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atrioventricular Nodal Reentrant Tachycardia
• Atrioventricular Reentrant Tachycardia

Exclusion criteria

• Atrial Tachycardia
• Organic supraventricular tachycardia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3,060 participants in 2 patient groups

Zero-fluoroscopic ablation

Experimental group

Description:

Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.

Treatment:

Device: Zero-fluoroscopic ablation

Conventional fluoroscopic ablation

Active Comparator group

Description:

Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.

Treatment:

Device: Conventional fluoroscopic ablation