Clinical trial NCT03151278: Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Arrhythmia
Atrial Premature Complexes
Atrial Tachycardia
Keywords: Fluoroscopy
Ablation
Three dimensional
Atrial arrhythmia
Radiation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Xinyang Central Hospital
name: Ningbo No. 1 Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: First Affiliated Hospital of Guangxi Medical University
name: Shenzhen Sun Yat-sen Cardiovascular Hospital
name: Guangdong Provincial People's Hospital
name: Zhongshan Hospital Xiamen University
First posted: 2017-05-12
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Atrial Tachycardia
* Atrial Premature Complexes

Exclusion Criteria:

* Left Atrial Premature Complexes
* Left Atrial Tachycardia

Primary outcomes:
measure: Total success rates
timeFrame: 3 months
Secondary outcomes:
measure: Total procedure time
timeFrame: during procedure
measure: Fluoroscopy time
timeFrame: during procedure
measure: Complications
timeFrame: 6 months
measure: Immediate success rate
timeFrame: 24 hours
measure: Recurrence rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Yan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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