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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF ablation | RF Ablation using specialized CFAE software |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF ablation, using specialized CFAE software | Procedure | RF ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Success | Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion | End of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total Ablation Time | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with persistent or longstanding persistent atrial fibrillation (AF), needing radiofrequency (RF) ablation
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Hôpital Saint Joseph | Principal Investigator |
| Franck Raczka, MD | CHU Arnaud de Villeneuve | Principal Investigator |
| Csaba Földesi, MD | Gottsegen György Országos Kardiológiai Intézet | Principal Investigator |
| Armin Luik, MD | Städtisches Klinikum Karlsruhe | Principal Investigator |
| Boris Schmidt, MD | Asklepios Klinik St. Georg | Principal Investigator |
| Ahmed Abdelaal, MD | Central Hospital, Nancy, France | Principal Investigator |
| Gilles-Sélim Lande-Abbey, MD | Hôpital Laënnec - CHU de Nantes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | France | ||||
| Hôpital Saint Joseph |
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| ID | Title | Description |
|---|---|---|
| FG000 | Number of Patients | Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency (RF) Ablation | RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age and gender were not collected for this trial. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Success | Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion | Patients with CFAE-guided RF catheter ablation | Posted | Number | 95% Confidence Interval | percentage achieving success | End of procedure |
|
|
Peri-procedural, up to duration of study
Procedure and/or device related
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency (RF) Ablation | RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tamponade | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Macours | Biosense Webster, EMEA | +32 2 7463076 | MNathalie@its.jnj.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 | Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes. | Procedural |
| Total Fluoroscopy Time | Mean total fluoroscopy time | 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. | Procedural |
| Bruno Cauchemez, MD | Clinique Ambroise Paré | Principal Investigator |
| Nicolas Lellouche, MD | Henri Mondor University Hospital | Principal Investigator |
| Fabrice Extramiana, MD | Hôpital Lariboisière Service de Rhytmologie | Principal Investigator |
| Julien Seitz, MD | Hôpital Privé Jacques Cartier Service de Rhytmologie | Principal Investigator |
| Marseille |
| 13001 |
| France |
| Hôpital Privé Jacques Cartier Service de Rhytmologie | Massy | France |
| CHU Arnaud de Villeneuve | Montpellier | 34295 | France |
| Clinique Ambroise Paré | Neuilly-sur-Seine | 92200 | France |
| Hôpital Les Franciscaines Service Rhythmologie | Nîmes | France |
| Hôpital Lariboisière Service de Rhytmologie | Paris | 75010 | France |
| Hôpital Laënnec - CHU de Nantes | Saint-Herblain | 44814 | France |
| Clinique Pasteur - Unité de Cardiologie interventionnelle | Toulouse | 31076 | France |
| CHU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
| Asklepios Klinik St. Georg | Hamburg | Germany |
| Städtisches Klinikum Karlsruhe | Karlsruhe | Germany |
| Gottsegen György Országos Kardiológiai Intézet | Budapest | Hungary |
| Number |
| participants |
|
| Sex/Gender, Customized | Age and gender were not collected for this trial. | Number | participants |
|
|
| Secondary | Total Ablation Time | Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported | Safety population with ablation time reported | Posted | Mean | Standard Deviation | minutes | Procedural |
|
|
|
| Secondary | 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 | Safety population with mapping time reported | Posted | Mean | Standard Deviation | minutes | Procedural |
|
|
|
| Secondary | Total Radiofrequency (RF) Duration | Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes. | Safety population with RF data reported | Posted | Mean | Standard Deviation | minutes | Procedural |
|
|
|
| Secondary | Total Fluoroscopy Time | Mean total fluoroscopy time | Safety population with fluoroscopy time reported | Posted | Mean | Standard Deviation | minutes | Procedural |
|
|
|
| Secondary | 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. | Safety population with non-outlier endpoint reported | Posted | Mean | Standard Deviation | points | Procedural |
|
|
|
| 13 |
| 205 |
| 3 |
| 205 |
| Sheath retained in femoral vein | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Epicardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Phrenic nerve injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pleural tamponade | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| D013568 |
| Pathological Conditions, Signs and Symptoms |