Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias (ZFA-RAA)

Tongji Hospital

Status: Completed

Conditions: Atrial Tachycardia; Atrial Arrhythmia; Atrial Premature Complexes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03151278

TJHCDD-ZF-RAA-20110131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atrial Tachycardia
• Atrial Premature Complexes

Exclusion criteria

• Left Atrial Premature Complexes
• Left Atrial Tachycardia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

Zero-fluoroscopy ablation

Experimental group

Description:

Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy.

Treatment:

Procedure: Zero-fluoroscopy ablation

Conventional fluoroscopy ablation

Active Comparator group

Description:

Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system.

Treatment:

Procedure: Conventional fluoroscopy ablation