European Carto® XP REgistry for Validating Specialized CFAE SOftware (EXPRESSO)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: RF ablation, using specialized CFAE software

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 Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• France
  • Créteil CEDEX, France
    • Hopital Henri Mondor
  • Marseille, France, 13001
    • Hôpital Saint Joseph
  • Massy, France
    • Hôpital Privé Jacques Cartier Service de Rhytmologie
  • Montpellier, France, 34295
    • CHU Arnaud de Villeneuve
  • Neuilly sur Seine, France, 92200
    • Clinique Ambroise Paré
  • Nîmes, France
    • Hôpital Les Franciscaines Service Rhythmologie
  • Paris CEDEX 10, France, 75010
    • Hôpital Lariboisière Service de Rhytmologie
  • St Herblain, France, 44814
    • Hopital Laennec - CHU de Nantes
  • Toulouse Cedex, France, 31076
    • Clinique Pasteur - Unité de Cardiologie interventionnelle
  • Vandoeuvre Les Nancy, France, 54500
    • Chu de Nancy
• Germany
  • Hamburg, Germany
    • Asklepios Klinik St. Georg
  • Karlsruhe, Germany
    • Städtisches Klinikum Karlsruhe
• Hungary
  • Budapest, Hungary
    • Gottsegen György Országos Kardiológiai Intézet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation

Description

Inclusion Criteria:

• Persistent or longstanding persistent AF

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RF ablation; RF Ablation using specialized CFAE software	Procedure: RF ablation, using specialized CFAE software; RF ablation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosense Webster EMEA
• Investigators: Principal Investigator: Armin Luik, MD, Städtisches Klinikum Karlsruhe; Principal Investigator: Jean-Paul Albenque, MD, Clinique Pasteur - Unité de Cardiologie interventionnelle; Principal Investigator: Agustin Bortone, MD, Hôpital Les Franciscaines Service Rhythmologie,; Principal Investigator: André Pisapia, MD, Hôpital Saint Joseph; Principal Investigator: Franck Raczka, MD, CHU Arnaud de Villeneuve; Principal Investigator: Csaba Földesi, MD, Gottsegen György Országos Kardiológiai Intézet; Principal Investigator: Boris Schmidt, MD, Asklepios Klinik St. Georg; Principal Investigator: Ahmed Abdelaal, MD, Chu de Nancy; Principal Investigator: Gilles-Sélim Lande-Abbey, MD, Hopital Laennec - CHU de Nantes; Principal Investigator: Bruno Cauchemez, MD, Clinique Ambroise Paré; Principal Investigator: Fabrice Extramiana, MD, Hôpital Lariboisière Service de Rhytmologie; Principal Investigator: Julien Seitz, MD, Hôpital Privé Jacques Cartier Service de Rhytmologie

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimate): December 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Persistent or longstanding persistent atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EXPRESSO