Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

Detailed Description
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The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration. The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Official Title
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Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Radio-frequency catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented atrial fibrillation in the 12-lead ECG or Holter ECG Paroxysmal symptomatic atrial fibrillation Ineffectiveness of antiarrhythmic medication ( at least 1 medication ) Age 18-75 years left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal ) A signed consent form Exclusion Criteria: Reversible etiology of atrial fibrillation Pregnancy Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure Intracardiac thrombus Contraindication to anticoagulation Thromboembolic event in the last 6 months Previous left atrial ablation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARTOUNIVU<br>Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system | Device: Radio-frequency catheter ablation<br>* Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.<br>|
| Active Comparator: CARTO3<br>Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique | Device: Radio-frequency catheter ablation<br>* Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time for each step of atrial fibrillation ablation procedure | Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations. | 1 day ( at the end of each step of atrial fibrillation ablation procedure) | 
| Fluoroscopy doses for each step of atrial fibrillation ablation procedure | Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations. | 1 day ( at the end of each step of atrial fibrillation ablation procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety | Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc. | All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days. | 
| Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy | number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation | 1 day ( at the end of each step of atrial fibrillation ablation procedure) | 
| Total time of atrial fibrillation ablation procedure as a measure of efficacy | procedure time (minute) | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluoroscopy exposure, paroxysmal atrial fibrillation Ablation, fluoroscopy, Atrial Fibrillation Ablation