NCT03151278

Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for the Ablation of Right Atrial Arrhythmias

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

Detailed description

Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures. Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel three-dimensional mapping systems such as Ensite NavX have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX is a promising system to guide catheters inside the cardiac chambers and vessels without the use of fluoroscopy. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

Conditions

• Atrial Arrhythmia
• Atrial Premature Complexes
• Atrial Tachycardia

Interventions

Type	Name	Description
PROCEDURE	Zero-fluoroscopy ablation	Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
PROCEDURE	Conventional fluoroscopy ablation	Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.

Timeline

• Start date: 2011-01-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2017-05-12
• Last updated: 2023-11-24

Locations

1 site across 1 country: China