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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
  Purpose
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.

Condition Intervention
Atrial Fibrillation
Procedure: RF ablation, using specialized CFAE software

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 206
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RF ablation
RF Ablation using specialized CFAE software
Procedure: RF ablation, using specialized CFAE software
RF ablation

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation
Criteria

Inclusion Criteria:

  • Persistent or longstanding persistent AF

Exclusion Criteria:

  • Previously underwent RF ablation for AF and patients with paroxysmal AF
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812916

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

Responsible Party: Biosense Webster EMEA
ClinicalTrials.gov Identifier: NCT00812916     History of Changes
Other Study ID Numbers: EXPRESSO 
Study First Received: December 19, 2008
Results First Received: November 12, 2015
Last Updated: January 13, 2016
Health Authority: Spain: Ethics Committee

Keywords provided by Biosense Webster, Inc.:
Persistent or longstanding persistent atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2016