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Completed

NCT Number: NCT00812916

European Carto® XP REgistry for Validating Specialized CFAE SOftware

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Henri Mondor, Créteil, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent or longstanding persistent AF

Exclusion criteria

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

Treatment and study plan

RF ablation, using specialized CFAE software

Procedure

RF ablation

Primary outcomes

  1. Acute Success

    Time frame: End of procedure

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

Secondary outcomes

  1. Total Ablation Time

    Time frame: Procedural

    Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported

  2. Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time

    Time frame: Procedural

    Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes

  3. Total Radiofrequency (RF) Duration

    Time frame: Procedural

    Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.

  4. Total Fluoroscopy Time

    Time frame: Procedural

    Mean total fluoroscopy time

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

    Time frame: Procedural

    Does not include 2 outliers with >300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure.

Sponsors and collaborators

Lead sponsor

Biosense Webster EMEA

Industry

Registry information

Official study title

EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware

Acronym: EXPRESSO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 22, 2008
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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