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European Carto® XP REgistry for Validating Specialized CFAE SOftware

NCT ID: NCT00812916

Last Updated: 2016-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RF ablation

RF Ablation using specialized CFAE software

RF ablation, using specialized CFAE software

Intervention Type PROCEDURE

RF ablation

Interventions

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RF ablation, using specialized CFAE software

RF ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Persistent or longstanding persistent AF

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster EMEA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul Albenque, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur - Unité de Cardiologie interventionnelle

Agustin Bortone, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Les Franciscaines Service Rhythmologie,

André Pisapia, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Joseph

Franck Raczka, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Arnaud de Villeneuve

Csaba Földesi, MD

Role: PRINCIPAL_INVESTIGATOR

Gottsegen György Országos Kardiológiai Intézet

Armin Luik, MD

Role: PRINCIPAL_INVESTIGATOR

Städtisches Klinikum Karlsruhe

Boris Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik St. Georg

Ahmed Abdelaal, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Gilles-Sélim Lande-Abbey, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Laënnec - CHU de Nantes

Bruno Cauchemez, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ambroise Paré

Nicolas Lellouche, MD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Fabrice Extramiana, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Lariboisière Service de Rhytmologie

Julien Seitz, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Jacques Cartier Service de Rhytmologie

Locations

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Hôpital Henri Mondor

Créteil, , France

Site Status

Hôpital Saint Joseph

Marseille, , France

Site Status

Hôpital Privé Jacques Cartier Service de Rhytmologie

Massy, , France

Site Status

CHU Arnaud de Villeneuve

Montpellier, , France

Site Status

Clinique Ambroise Paré

Neuilly-sur-Seine, , France

Site Status

Hôpital Les Franciscaines Service Rhythmologie

Nîmes, , France

Site Status

Hôpital Lariboisière Service de Rhytmologie

Paris, , France

Site Status

Hôpital Laënnec - CHU de Nantes

Saint-Herblain, , France

Site Status

Clinique Pasteur - Unité de Cardiologie interventionnelle

Toulouse, , France

Site Status

CHU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status

Gottsegen György Országos Kardiológiai Intézet

Budapest, , Hungary

Site Status

Countries

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France Germany Hungary

Other Identifiers

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EXPRESSO

Identifier Type: -

Identifier Source: org_study_id

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