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

December 19, 2008
May 27, 2014
August 2008
September 2010   (final data collection date for primary outcome measure)
The primary efficacy endpoint of this registry is the acute success of the procedure. [ Time Frame: acute ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812916 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
European Carto XP Registry for Validating Specialized CFAE Software
A Prospective Observational Multi-centre Registry for Validating Specialized CFAE Software in Patients With Persistent or Longstanding Persistent Atrial Fibrillation

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with persistent or longstanding persistent AF, needing RF ablation

Atrial Fibrillation
Procedure: RF ablation, using specialized CFAE software
RF ablation
RF ablation
RF Ablation using specialized CFAE software
Intervention: Procedure: RF ablation, using specialized CFAE software
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
December 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • persistent or longstanding persistent AF

Exclusion Criteria:

  • previously underwent RF ablation for AF and patients with paroxysmal AF
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary
 
NCT00812916
EXPRESSO
No
Biosense Webster, Inc. ( Biosense Webster EMEA )
Biosense Webster EMEA
Not Provided
Not Provided
Biosense Webster, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP