European Carto® XP REgistry for Validating Specialized CFAE SOftware

Study Overview
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Brief Summary
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The purpose of this prospective observational study (registry) is to determine the acute success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent atrial fibrillation (AF) in routine clinical practice.

Detailed Description
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This was a prospective, multi-center, observational registry study evaluating CARTO® XP CFAE Software (CFAE Software) in subjects with chronic AF requiring CFAE-guided RFCA. Use of the CARTO® 3 System (including CFAE Software) was also allowed. The primary efficacy endpoint was the acute success rate of CFAE-guided radiofrequency catheter ablation (RFCA) using the CFAE Software. Acute success is defined as the subject achieving sinus rhythm at the end of the procedure without electrical or pharmaceutical cardioversion. Secondary endpoints consisted of measures of efficacy (example, performance of the CFAE Software) and of safety (example, number of procedure-related adverse events).

Official Title
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EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: RF ablation, using specialized CFAE software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent or longstanding persistent AF Exclusion Criteria: Previously underwent RF ablation for AF and patients with paroxysmal AF
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RF ablation<br>RF Ablation using specialized CFAE software | Procedure: RF ablation, using specialized CFAE software<br>* RF ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Success | Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion | End of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Ablation Time | Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported | Procedural | 
| Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time | Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes | Procedural | 
| Total Radiofrequency (RF) Duration | Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes. | Procedural | 
| Total Fluoroscopy Time | Mean total fluoroscopy time | Procedural | 
| Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points | Does not include 2 outliers with >300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure. | Procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent or longstanding persistent atrial fibrillation