European Carto XP Registry for Validating Specialized CFAE Software (EXPRESSO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Biosense Webster EMEA.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biosense Webster EMEA
ClinicalTrials.gov Identifier:
NCT00812916
First received: December 19, 2008
Last updated: May 25, 2009
Last verified: May 2009
  Purpose

The purpose of this prospective observational study (registry) is to determine the acute success rate of a 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 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: A Prospective Observational Multi-Centre Registry for Validating Specialized CFAE Software in Patients With Persistent or Longstanding Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biosense Webster EMEA:

Primary Outcome Measures:
  • The primary efficacy endpoint of this registry is the acute success of the procedure. [ Time Frame: acute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with persistent or longstanding persistent AF, needing 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812916

Locations
France
CHU Lille Recruiting
Lille, France, 59037
Contact: Francois Brigadeau, Dr.    +33 3 20 44 59 62      
Hopital Saint Joseph Recruiting
Marseille, France, 13001
Contact: André Pisapia, Dr.    +33 4 91 74 20 11      
Contact: Michel Bremondy, Dr.    +33 4 91 74 20 11      
CHU Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Jean-Luc Pasquie, Dr.    +33 4 67 33 67 33      
Contact: Franck Raczka, Dr.    +33 4 67 33 67 33      
CHU Hôpital de Brabois Recruiting
Nancy, France, 54500
Contact: Ahmed Abdelaal, Dr.    +33 3 83 85 85 85      
CHU Nantes Recruiting
Nantes, France, 44000
Contact: Gilles Lande, Dr.    +33 2 40 08 33 33      
Contact: Selim Abbey, Dr.    +33 2 40 08 33 33      
Ambroise Paré Recruiting
Neuilly, France, 92200
Contact: Bruno Cauchemez, Dr.    +33 1 46 41 88 88      
Hopital Les Franciscaines Recruiting
Nimes, France
Contact: Augustine Bortone, Dr.    +33 8 26 30 50 00      
Hôpital Lariboisière Not yet recruiting
Paris, France, 75010
Contact: Fabrice Extramiana, Dr.    +33 1 42 17 76 60      
Clinique Pasteur Not yet recruiting
Toulouse, France, 31076
Contact: Jean-Paul Albenque, Dr.    +33 5 62 21 31 31      
Germany
Klinik St. Georg Recruiting
Hamburg, Germany
Contact: Boris Schmidt, Dr.    +49 40 18 18 85 2305      
Stadtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Germany
Contact: Armin Luik, Dr.    +49 7 219 74 2901      
Universität Rostock Not yet recruiting
Rostock, Germany
Contact: Dietmar Bansch, Prof.    +49 38 14 94 77 06      
Hungary
GOKI Terminated
Budapest, Hungary
Sponsors and Collaborators
Biosense Webster EMEA
  More Information

No publications provided

Responsible Party: Ilse Van Keer, Biosense Webster EMEA
ClinicalTrials.gov Identifier: NCT00812916     History of Changes
Other Study ID Numbers: EXPRESSO
Study First Received: December 19, 2008
Last Updated: May 25, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by Biosense Webster EMEA:
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 April 17, 2014