Clinical trial NCT03042078: Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Supraventricular Tachycardia
Keywords: Fluoroscopy
Ablation
Three dimensional
Paroxysmal supraventricular tachycardia
Radiation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Xiangyang Central Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Guangdong Provincial People's Hospital
name: Morristown Memorial Hospital
name: Beijing Anzhen Hospital
name: Ningbo No. 1 Hospital
First posted: 2017-02-03
Enrollment: 3060
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Atrioventricular Nodal Reentrant Tachycardia
* Atrioventricular Reentrant Tachycardia

Exclusion Criteria:

* Atrial Tachycardia
* Organic supraventricular tachycardia

Primary outcomes:
measure: Procedural success rate
timeFrame: one year
Secondary outcomes:
measure: Complications
timeFrame: one year
measure: Immediate success rate
timeFrame: one day
measure: Recurrence Rate
timeFrame: 1 year
measure: Total procedure time
timeFrame: one day
measure: Fluoroscopy time
timeFrame: one day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital Wuhan, Hubei China
name: Yan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chen G, Wang Y, Proietti R, Wang X, Ouyang F, Ma CS, Yu RH, Zhao C, Ma K, Qiu J, Liu Q, Wang DW. Zero-fluoroscopy approach for ablation of supraventricular tachycardia using the Ensite NavX system: a multicenter experience. BMC Cardiovasc Disord. 2020 Feb 3;20(1):48. doi: 10.1186/s12872-020-01344-0.