European Carto® XP REgistry for Validating Specialized CFAE SOftware

Atrial Fibrillation Clinical Trial

— EXPRESSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812916
• Other study ID #: EXPRESSO
• Status: Completed
• Phase: N/A
• First received: December 19, 2008
• Last updated: January 13, 2016
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Persistent or longstanding persistent AF

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• RF ablation, using specialized CFAE software
RF ablation

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil CEDEX
France	Hôpital Saint Joseph	Marseille
France	Hôpital Privé Jacques Cartier Service de Rhytmologie	Massy
France	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 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
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Städtisches Klinikum Karlsruhe	Karlsruhe
Hungary	Gottsegen György Országos Kardiológiai Intézet	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster EMEA

Countries where clinical trial is conducted

France,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Success	Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion	End of procedure	No
Secondary	Total Ablation Time	Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported	Procedural	No
Secondary	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	No
Secondary	Total Radiofrequency (RF) Duration	Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.	Procedural	No
Secondary	Total Fluoroscopy Time	Mean total fluoroscopy time	Procedural	Yes
Secondary	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	No