European Carto® XP REgistry for Validating Specialized CFAE SOftware

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: RF ablation, using specialized CFAE software

• Registration Number: NCT00812916
• Lead Sponsor: Biosense Webster EMEA

Brief Summary

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

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).

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Results First Submitted: 2015-11-12
• Results First Submitted QC: 2015-11-12
• Results First Posted: 2015-12-16
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Persistent or longstanding persistent AF

Exclusion Criteria

• Previously underwent RF ablation for AF and patients with paroxysmal AF

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RF ablation	RF ablation, using specialized CFAE software	RF Ablation using specialized CFAE software

Primary Outcome Measures

Name	Time	Method
Acute Success	End of procedure	Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion

Secondary Outcome Measures

Name	Time	Method
Total Ablation Time	Procedural	Total time of ablation with exception of 10 outliers with \>180 minutes of total ablation time reported
Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time	Procedural	Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of \>120 minutes
Total Radiofrequency (RF) Duration	Procedural	Total duration of all radiofrequency applications with exception of 12 outliers recording \>150 minutes.
Total Fluoroscopy Time	Procedural	Mean total fluoroscopy time
Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points	Procedural	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.

Trial Locations

Locations (13)

Hôpital Saint Joseph; 🇫🇷 Marseille, France

Hôpital Privé Jacques Cartier Service de Rhytmologie; 🇫🇷 Massy, France

Hôpital Henri Mondor; 🇫🇷 Créteil CEDEX, France

CHU Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Hôpital Lariboisière Service de Rhytmologie; 🇫🇷 Paris CEDEX 10, France

Hôpital Laënnec - CHU de Nantes; 🇫🇷 St Herblain, France

Clinique Pasteur - Unité de Cardiologie interventionnelle; 🇫🇷 Toulouse Cedex, France

CHU de Nancy; 🇫🇷 Vandoeuvre Les Nancy, France

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Gottsegen György Országos Kardiológiai Intézet; 🇭🇺 Budapest, Hungary

Clinique Ambroise Paré; 🇫🇷 Neuilly sur Seine, France

Hôpital Les Franciscaines Service Rhythmologie; 🇫🇷 Nîmes, France

Städtisches Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Germany