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: May 27, 2014
Last verified: May 2014
  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, Inc.:

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 ]

Enrollment: 206
Study Start Date: August 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

  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
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
CHU Lille
Lille, France, 59037
Hopital Saint Joseph
Marseille, France, 13001
CHU Arnaud de Villeneuve
Montpellier, France, 34295
CHU Hôpital de Brabois
Nancy, France, 54500
CHU Nantes
Nantes, France, 44000
Ambroise Paré
Neuilly, France, 92200
Hopital Les Franciscaines
Nimes, France
Hôpital Lariboisière
Paris, France, 75010
Clinique Pasteur
Toulouse, France, 31076
Germany
Klinik St. Georg
Hamburg, Germany
Stadtisches Klinikum Karlsruhe
Karlsruhe, Germany
Universität Rostock
Rostock, Germany
Hungary
GOKI
Budapest, Hungary
Sponsors and Collaborators
Biosense Webster EMEA
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc. ( Biosense Webster EMEA )
ClinicalTrials.gov Identifier: NCT00812916     History of Changes
Other Study ID Numbers: EXPRESSO
Study First Received: December 19, 2008
Last Updated: May 27, 2014
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 July 23, 2014