Clinical trial NCT00812916: European Carto® XP REgistry for Validating Specialized CFAE SOftware
Official title: EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Persistent or longstanding persistent atrial fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation

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).

Eligibility criteria: Inclusion Criteria:

* Persistent or longstanding persistent AF

Exclusion Criteria:

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

Primary outcomes:
measure: Acute Success
timeFrame: End of procedure
Secondary outcomes:
measure: Total Ablation Time
timeFrame: Procedural
measure: Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time
timeFrame: Procedural
measure: Total Radiofrequency (RF) Duration
timeFrame: Procedural
measure: Total Fluoroscopy Time
timeFrame: Procedural
measure: Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points
timeFrame: Procedural
Other outcomes:
Locations:
city: Créteil CEDEX
country: France
facility: Hôpital Henri Mondor
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier Service de Rhytmologie
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Neuilly sur Seine
country: France
facility: Clinique Ambroise Paré
city: Nîmes
country: France
facility: Hôpital Les Franciscaines Service Rhythmologie
city: Paris CEDEX 10
country: France
facility: Hôpital Lariboisière Service de Rhytmologie
city: St Herblain
country: France
facility: Hôpital Laënnec - CHU de Nantes
city: Toulouse Cedex
country: France
facility: Clinique Pasteur - Unité de Cardiologie interventionnelle
city: Vandoeuvre Les Nancy
country: France
facility: CHU de Nancy
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet
Study officials:
affiliation: Clinique Pasteur - Unité de Cardiologie interventionnelle
name: Jean-Paul Albenque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Les Franciscaines Service Rhythmologie,
name: Agustin Bortone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint Joseph
name: André Pisapia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Arnaud de Villeneuve
name: Franck Raczka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gottsegen György Országos Kardiológiai Intézet
name: Csaba Földesi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Städtisches Klinikum Karlsruhe
name: Armin Luik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asklepios Klinik St. Georg
name: Boris Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Ahmed Abdelaal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Laënnec - CHU de Nantes
name: Gilles-Sélim Lande-Abbey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Ambroise Paré
name: Bruno Cauchemez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henri Mondor University Hospital
name: Nicolas Lellouche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Lariboisière Service de Rhytmologie
name: Fabrice Extramiana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Privé Jacques Cartier Service de Rhytmologie
name: Julien Seitz, MD
role: PRINCIPAL_INVESTIGATOR
References: