Atrial Fibrillation
Conditions
Keywords
Persistent or longstanding persistent atrial fibrillation
Brief 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 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).
Interventions
PROCEDURERF ablation, using specialized CFAE software
RF ablation
Sponsors
Biosense Webster EMEA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Persistent or longstanding persistent AF
Exclusion criteria
* Previously underwent RF ablation for AF and patients with paroxysmal AF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Success | End of procedure | Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Ablation Time | Procedural | Total time of ablation with exception of 10 outliers with \>180 minutes of total ablation time reported |
| Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time | Procedural | Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of \>120 minutes |
| Total Radiofrequency (RF) Duration | Procedural | Total duration of all radiofrequency applications with exception of 12 outliers recording \>150 minutes. |
| Total Fluoroscopy Time | Procedural | Mean total fluoroscopy time |
| Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points | 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. |
Countries
France, Germany, Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency (RF) Ablation RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software | 206 |
| Total | 206 |
Baseline characteristics
| Characteristic | Radiofrequency (RF) Ablation |
|---|---|
| Age, Customized Not Collected | 206 participants |
| Sex/Gender, Customized Not Collected | 206 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 205 |
| serious Total, serious adverse events | 13 / 205 |
Outcome results
Primary
Acute Success
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
Time frame: End of procedure
Population: Patients with CFAE-guided RF catheter ablation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency (RF) Ablation | Acute Success | 48.8 percentage achieving success |
Secondary
Total Ablation Time
Total time of ablation with exception of 10 outliers with \>180 minutes of total ablation time reported
Time frame: Procedural
Population: Safety population with ablation time reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation | Total Ablation Time | 61.4 minutes | Standard Deviation 42 |
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
Time frame: Procedural
Population: Safety population with mapping time reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation | Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time | 27.7 minutes | Standard Deviation 15.4 |
Secondary
Total Fluoroscopy Time
Mean total fluoroscopy time
Time frame: Procedural
Population: Safety population with fluoroscopy time reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation | Total Fluoroscopy Time | 43.3 minutes | Standard Deviation 28.6 |
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.
Time frame: Procedural
Population: Safety population with non-outlier endpoint reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation | Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points | 33.5 points | Standard Deviation 43.1 |
Secondary
Total Radiofrequency (RF) Duration
Total duration of all radiofrequency applications with exception of 12 outliers recording \>150 minutes.
Time frame: Procedural
Population: Safety population with RF data reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation | Total Radiofrequency (RF) Duration | 76.2 minutes | Standard Deviation 24.8 |