European Carto® XP REgistry for Validating Specialized CFAE SOftware

NCT00812916 | Completed Results

• 1 other identifier: EXPRESSO
• Study Type: observational
• Target: 206
• Locations: 3 countries
• Sites: 13

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.

Conditions

Atrial Fibrillation

Keywords

Persistent or longstanding persistent atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Acute Success

  Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion

  End of procedure

Secondary Outcomes (5)

• Total Ablation Time

  Procedural

• Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time

  Procedural

• Total Radiofrequency (RF) Duration

  Procedural

• Total Fluoroscopy Time

  Procedural

• Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points

  Procedural

Study Arms (1)

RF ablation

RF Ablation using specialized CFAE software

Procedure: RF ablation, using specialized CFAE software

Interventions

RF ablation, using specialized CFAE software PROCEDURE

RF ablation

RF ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation

You may qualify if:

• Persistent or longstanding persistent AF

You may not qualify if:

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

Sponsors & Collaborators

• Biosense Webster EMEA: lead

Study Sites (13)

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Saint Joseph

Marseille, 13001, France

Location

Hôpital Privé Jacques Cartier Service de Rhytmologie

Massy, France

Location

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

Hôpital Les Franciscaines Service Rhythmologie

Nîmes, France

Location

Hôpital Lariboisière Service de Rhytmologie

Paris, 75010, France

Location

Hôpital Laënnec - CHU de Nantes

Saint-Herblain, 44814, France

Location

Clinique Pasteur - Unité de Cardiologie interventionnelle

Toulouse, 31076, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

Gottsegen György Országos Kardiológiai Intézet

Budapest, Hungary

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nathalie Macours
• Organization: Biosense Webster, EMEA

MNathalie@its.jnj.com

+32 2 7463076

Study Officials

• 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

  Central Hospital, Nancy, France

  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

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

• Fabrice Extramiana, MD

  Hôpital Lariboisière Service de Rhytmologie

  PRINCIPAL INVESTIGATOR

• Julien Seitz, MD

  Hôpital Privé Jacques Cartier Service de Rhytmologie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 8, 2016
• Results First Posted: December 16, 2015

Record last verified: 2016-01

Locations

DE (2); FR (10); HU (1)