Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

Not Applicable

Completed

• Conditions: Atrial Premature Complexes; Atrial Arrhythmia; Atrial Tachycardia
• Interventions: Procedure: Zero-fluoroscopy ablation; Procedure: Conventional fluoroscopy ablation

• Registration Number: NCT03151278
• Lead Sponsor: Tongji Hospital

Brief 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Atrial Tachycardia
• Atrial Premature Complexes

Exclusion Criteria

• Left Atrial Premature Complexes
• Left Atrial Tachycardia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zero-fluoroscopy ablation	Zero-fluoroscopy ablation	Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy.
Conventional fluoroscopy ablation	Conventional fluoroscopy ablation	Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system.

Primary Outcome Measures

Name	Time	Method
Total success rates	3 months	The patients have no related arrhythias or recurrence during follow up.

Secondary Outcome Measures

Name	Time	Method
Total procedure time	during procedure	The patients have no related arrhythias or recurrence during follow up.
Recurrence rate	6 months	The patients have no related arrhythias or recurrence during follow up.
Immediate success rate	24 hours	Electrophysiologic study shows success of ablation
Fluoroscopy time	during procedure	From skin puncture to withdrawal of all the catheters.
Complications	6 months	The patients have no related complications during follow up.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China