European Carto® XP REgistry for Validating Specialized CFAE SOftware

Last updated: January 13, 2016
Sponsor: Biosense Webster EMEA
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Arrhythmia

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT00812916
EXPRESSO
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Persistent or longstanding persistent AF

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 206
Study Start date:
September 01, 2008
Estimated Completion Date:
December 31, 2010

Study 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).

Connect with a study center

  • Hôpital Henri Mondor

    Créteil CEDEX,
    France

    Site Not Available

  • CHU Lille

    Lille, 59037
    France

    Site Not Available

  • Hôpital Saint Joseph

    Marseille, 13001
    France

    Site Not Available

  • Hôpital Privé Jacques Cartier Service de Rhytmologie

    Massy,
    France

    Site Not Available

  • CHU Arnaud de Villeneuve

    Montpellier, 34295
    France

    Site Not Available

  • CHU Hôpital de Brabois

    Nancy, 54500
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44000
    France

    Site Not Available

  • Ambroise Paré

    Neuilly, 92200
    France

    Site Not Available

  • Clinique Ambroise Paré

    Neuilly sur Seine, 92200
    France

    Site Not Available

  • Hopital Les Franciscaines

    Nimes,
    France

    Site Not Available

  • Hôpital Les Franciscaines Service Rhythmologie

    Nîmes,
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris, 75010
    France

    Site Not Available

  • Hôpital Lariboisière Service de Rhytmologie

    Paris CEDEX 10, 75010
    France

    Site Not Available

  • Hôpital Laënnec - CHU de Nantes

    St Herblain, 44814
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, 31076
    France

    Site Not Available

  • Clinique Pasteur - Unité de Cardiologie interventionnelle

    Toulouse Cedex, 31076
    France

    Site Not Available

  • CHU de Nancy

    Vandoeuvre Les Nancy, 54500
    France

    Site Not Available

  • Asklepios Klinik St. Georg

    Hamburg,
    Germany

    Site Not Available

  • Städtisches Klinikum Karlsruhe

    Karlsruhe,
    Germany

    Site Not Available

  • Universität Rostock

    Rostock,
    Germany

    Site Not Available

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest,
    Hungary

    Site Not Available

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