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.
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 Type
OBSERVATIONAL
Enrollment
206
RF ablation
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Joseph
Marseille, France
Hôpital Privé Jacques Cartier Service de Rhytmologie
Massy, France
Acute Success
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
Time frame: End of procedure
Total Ablation Time
Total time of ablation with exception of 10 outliers with \>180 minutes of total ablation time reported
Time frame: 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
Time frame: Procedural
Total Radiofrequency (RF) Duration
Total duration of all radiofrequency applications with exception of 12 outliers recording \>150 minutes.
Time frame: Procedural
Total Fluoroscopy Time
Mean total fluoroscopy time
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU Arnaud de Villeneuve
Montpellier, France
Clinique Ambroise Paré
Neuilly-sur-Seine, France
Hôpital Les Franciscaines Service Rhythmologie
Nîmes, France
Hôpital Lariboisière Service de Rhytmologie
Paris, France
Hôpital Laënnec - CHU de Nantes
Saint-Herblain, France
Clinique Pasteur - Unité de Cardiologie interventionnelle
Toulouse, France
CHU de Nancy
Vandœuvre-lès-Nancy, France
...and 3 more locations
Time frame: Procedural