NCT03042078

Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,060 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Paroxysmal Supraventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Zero-fluoroscopic ablation	Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
DEVICE	Conventional fluoroscopic ablation	Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-02-01
• Completion: 2018-12-01
• First posted: 2017-02-03
• Last updated: 2023-11-24

Locations

1 site across 1 country: China