European Carto® XP REgistry for Validating Specialized CFAE SOftware (EXPRESSO)

January 13, 2016 updated by: Biosense Webster EMEA

EXPRESSO - 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil CEDEX, France
        • Hopital Henri Mondor
      • Marseille, France, 13001
        • Hopital Saint Joseph
      • Massy, France
        • Hôpital Privé Jacques Cartier Service de Rhytmologie
      • Montpellier, France, 34295
        • CHU Arnaud de Villeneuve
      • Neuilly sur Seine, France, 92200
        • Clinique Ambroise Pare
      • Nîmes, France
        • Hôpital Les Franciscaines Service Rhythmologie
      • Paris CEDEX 10, France, 75010
        • Hôpital Lariboisière Service de Rhytmologie
      • St Herblain, France, 44814
        • Hopital Laennec - CHU de Nantes
      • Toulouse Cedex, France, 31076
        • Clinique Pasteur - Unité de Cardiologie interventionnelle
      • Vandoeuvre Les Nancy, France, 54500
        • CHU de Nancy
  • Germany
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Karlsruhe, Germany
        • Stadtisches Klinikum Karlsruhe
  • Hungary
      • Budapest, Hungary
        • Gottsegen György Országos Kardiológiai Intézet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Persistent or longstanding persistent AF

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RF ablation
RF Ablation using specialized CFAE software
Procedure: RF ablation, using specialized CFAE software
RF ablation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acute Success
Time Frame: End of procedure
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
End of procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Ablation Time
Time Frame: Procedural
Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported
Procedural
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
Procedural
Total Radiofrequency (RF) Duration
Time Frame: Procedural
Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.
Procedural
Total Fluoroscopy Time
Time Frame: Procedural
Mean total fluoroscopy time
Procedural
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.
Procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster EMEA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Armin Luik, MD, Stadtisches Klinikum Karlsruhe
  • Principal Investigator: 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, Hopital Saint Joseph
  • Principal Investigator: Franck Raczka, MD, CHU Arnaud de Villeneuve
  • Principal Investigator: Csaba Földesi, MD, Gottsegen György Országos Kardiológiai Intézet
  • Principal Investigator: Boris Schmidt, MD, Asklepios Klinik St. Georg
  • Principal Investigator: Ahmed Abdelaal, MD, CHU de Nancy
  • Principal Investigator: Gilles-Sélim Lande-Abbey, MD, Hopital Laennec - CHU de Nantes
  • Principal Investigator: Bruno Cauchemez, MD, Clinique Ambroise Pare
  • Principal Investigator: Fabrice Extramiana, MD, Hôpital Lariboisière Service de Rhytmologie
  • Principal Investigator: Julien Seitz, MD, Hôpital Privé Jacques Cartier Service de Rhytmologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EXPRESSO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings