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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc. ( Biosense Webster EMEA )
ClinicalTrials.gov Identifier:
NCT00812916
First received: December 19, 2008
Last updated: January 13, 2016
Last verified: January 2016

December 19, 2008
January 13, 2016
September 2008
September 2010   (final data collection date for primary outcome measure)
Acute Success [ Time Frame: End of procedure ] [ Designated as safety issue: No ]
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
The primary efficacy endpoint of this registry is the acute success of the procedure. [ Time Frame: acute ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00812916 on ClinicalTrials.gov Archive Site
  • Total Ablation Time [ Time Frame: Procedural ] [ Designated as safety issue: No ]
    Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported
  • Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time [ Time Frame: Procedural ] [ Designated as safety issue: No ]
    Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes
  • Total Radiofrequency (RF) Duration [ Time Frame: Procedural ] [ Designated as safety issue: No ]
    Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.
  • Total Fluoroscopy Time [ Time Frame: Procedural ] [ Designated as safety issue: Yes ]
    Mean total fluoroscopy time
  • Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points [ Time Frame: Procedural ] [ Designated as safety issue: No ]
    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.
  • Performance of the CFAE software [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Procedural time point when the patient rhythm converts into Normal Sinus Rhythm [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Total CFAE mapping and ablation time [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Total RF Duration [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Safety: frequency and type of device / procedure related adverse event [ Time Frame: acute ] [ Designated as safety issue: Yes ]
  • Total Fluoroscopy Time [ Time Frame: acute ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
European Carto® XP REgistry for Validating Specialized CFAE SOftware
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.
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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation
Atrial Fibrillation
Procedure: RF ablation, using specialized CFAE software
RF ablation
RF ablation
RF Ablation using specialized CFAE software
Intervention: Procedure: RF ablation, using specialized CFAE software
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
December 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Persistent or longstanding persistent AF

Exclusion Criteria:

  • Previously underwent RF ablation for AF and patients with paroxysmal AF
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary
Belgium,   Denmark,   Netherlands,   Poland,   Spain
 
NCT00812916
EXPRESSO
No
Not Provided
Not Provided
Biosense Webster EMEA
Biosense Webster EMEA
Not Provided
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: Armin Luik, MD Städtisches Klinikum Karlsruhe
Principal Investigator: Boris Schmidt, MD Asklepios Klinik St. Georg
Principal Investigator: Ahmed Abdelaal, MD CHU de Nancy
Principal Investigator: Gilles-Sélim Lande-Abbey, MD Hôpital Laënnec - CHU de Nantes
Principal Investigator: Bruno Cauchemez, MD Clinique Ambroise Paré
Principal Investigator: Nicolas Lellouche, MD Hôpital Henri Mondor
Principal Investigator: Fabrice Extramiana, MD Hôpital Lariboisière Service de Rhytmologie
Principal Investigator: Julien Seitz, MD Hôpital Privé Jacques Cartier Service de Rhytmologie
Biosense Webster, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP