Real Zero Fluoroscopy Catheter Ablation.

Study Overview
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Brief Summary
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A Retrospective Propensity Matched Study comparing: real zero fluoroscopy catheter ablation conventional fluoroscopy catheter ablation without 3D system conventional fluoroscopy catheter ablation with 3D system

Detailed Description
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Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias. The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who: underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support Covariates for matching will be: arrhythmia type age of a patient number of diagnostic catheters used during a procedure type of a diagnostic catheter used during a procedure]

Official Title
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Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study

Conditions
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Atrial Arrhythmia, Ventricular Arrythmia, Arrhythmia, Arrhythmias, Cardiac

Intervention / Treatment
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* Procedure: Zero fluoroscopy ablation
* Procedure: Conventional ablation without 3D
* Procedure: Conventional ablation with 3D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: right atrial tachycardia right atrial premature complexes AVNRT right atrial AVRT/WPW right ventricle tachycardia / right ventricle premature complexes Exclusion Criteria: left atrium arrhythmia left ventricle arrhythmia

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Zero fluoro<br>Patients in whom Zero fluoroscopy ablation was performed under the guidance of Ensite for mapping and ablation and fluoroscopy will not be used during the procedure. | Procedure: Zero fluoroscopy ablation<br>* Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance<br>* Other names: Zero fluoro;|
| Conventional ablation without 3D<br>Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic guidance only. Additional use of Ensite/Carto/Localisa for mapping was not allowed. | Procedure: Conventional ablation without 3D<br>* Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed<br>* Other names: Conventional fluoroscopy ablation without 3D;|
| Conventional ablation with 3D<br>Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic and Ensite/Carto guidance and ablation during the procedure. Use of fluoroscopy and additional Ensite/Carto for mapping and ablation was mandatory. | Procedure: Conventional ablation with 3D<br>* Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)<br>* Other names: Conventional fluoroscopy ablation with 3D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rates | arrhythmia recurrence within 3 months since the index procedure | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time | total procedure time measured as needle to needle time | during procedure | 
| Fluoroscopy time | total fluoroscopy time during procedure | during procedure | 
| Acute procedural success | acute procedural success defined as arhhythia elimination | 10-30 minutes | 
| Recurrence rate | arrhythmia recurrence within 6 months since the index procedure | 6 months | 
| Acute Complications rate | Procedural Complications procedure | during procedure | 
| All Complications rate | Procedural Complications and Complications within 6 months since the index procedure | 6 months | 
| The length of stay during the hospitalization | Number of hospital days for ablation procedure from admission to discharge | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Arrhythmia, Ventricular Arrythmia, ablation, fluoroscopy