Atrial FibrillationEXPRESSONCT00812916
European Carto® XP REgistry for Validating Specialized CFAE SOftware
An observational study of Atrial Fibrillation, run by Biosense Webster EMEA at 13 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- RF ablation, using specialized CFAE software
- Type of treatment
- Surgery or procedure
- How many people
- 206 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Sep 2008to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation
Who may be able to join
- Persistent or longstanding persistent AF
Who cannot join
- Previously underwent RF ablation for AF and patients with paroxysmal AF
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
France10 sites
Hôpital Henri Mondor
Créteil
Hôpital Saint Joseph
Marseille, 13001
Hôpital Privé Jacques Cartier Service de Rhytmologie
Massy
CHU Arnaud de Villeneuve
Montpellier, 34295
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
Hôpital Les Franciscaines Service Rhythmologie
Nîmes
Hôpital Lariboisière Service de Rhytmologie
Paris, 75010
Hôpital Laënnec - CHU de Nantes
Saint-Herblain, 44814
Clinique Pasteur - Unité de Cardiologie interventionnelle
Toulouse, 31076
CHU de Nancy
Vandœuvre-lès-Nancy, 54500
Germany2 sites
Asklepios Klinik St. Georg
Hamburg
Städtisches Klinikum Karlsruhe
Karlsruhe
About this study
Official title: 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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- RF ablation, using specialized CFAE software
- Keywords
- Persistent or longstanding persistent atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablation, using specialized CFAE softwareProcedure or surgery
RF ablation
| Study group | Role | What they receive |
|---|---|---|
| RF ablation | RF Ablation using specialized CFAE software Receives: Procedure: RF ablation, using specialized CFAE software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Success
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
Measured: End of procedure
Secondary outcomes (5)
Total Ablation Time
Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported
Measured: Procedural
Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time
Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes
Measured: Procedural
Total Radiofrequency (RF) Duration
Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.
Measured: Procedural
Total Fluoroscopy Time
Mean total fluoroscopy time
Measured: Procedural
Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points
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.
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster EMEA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Albenque, MD, Principal investigator, Clinique Pasteur - Unité de Cardiologie interventionnelleAgustin Bortone, MD, Principal investigator, Hôpital Les Franciscaines Service Rhythmologie,André Pisapia, MD, Principal investigator, Hôpital Saint JosephFranck Raczka, MD, Principal investigator, CHU Arnaud de VilleneuveCsaba Földesi, MD, Principal investigator, Gottsegen György Országos Kardiológiai IntézetArmin Luik, MD, Principal investigator, Städtisches Klinikum KarlsruheBoris Schmidt, MD, Principal investigator, Asklepios Klinik St. GeorgAhmed Abdelaal, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812916
- Sponsor's protocol ID
- EXPRESSO
- Acronym
- EXPRESSO
- Status last verified
- Jan 2016
- First submitted
- 19 Dec 2008
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware
- ClinicalTrials.gov ID
- NCT00812916
- Acronym / sponsor ID
- EXPRESSO / EXPRESSO
- Conditions
- Atrial Fibrillation
- Keywords
- Persistent or longstanding persistent atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Biosense Webster EMEAIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 16 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF ablation | – | Procedure: RF ablation, using specialized CFAE softwareRF Ablation using specialized CFAE software |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation
Key inclusion criteria (1 listed)
- Persistent or longstanding persistent AF
Key exclusion criteria (1 listed)
- Previously underwent RF ablation for AF and patients with paroxysmal AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF ablation, using specialized CFAE softwareRF ablation | Procedure or surgery | RF ablation |
Primary outcome
Acute Success
Time frame: End of procedure
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
5 secondary outcomes
Total Ablation Time
Time frame: Procedural
Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time
Time frame: Procedural
Total Radiofrequency (RF) Duration
Time frame: Procedural
Total Fluoroscopy Time
Time frame: Procedural
Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points
Time frame: Procedural
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Albenque, MD principal investigator
Clinique Pasteur - Unité de Cardiologie interventionnelle
Agustin Bortone, MD principal investigator
Hôpital Les Franciscaines Service Rhythmologie,
André Pisapia, MD principal investigator
Hôpital Saint Joseph
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Biosense Webster EMEA at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Success (time frame: End of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016; AzTrials last refreshed its copy on 30 Oct 2026.