Atrial Fibrillation
Conditions
Brief summary
To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the SCI 30-40 setting of CARTO CFAE algorithm.
Detailed description
This study is observational : This substrate ablation method is performed routinely in the centers involved in the study so, patients were not assigned by the investigators to undergo a specific procedure because of the study, in all cases patient would have beneficiate from this substrate mapping ablation method. We assessed procedural and follow up outcomes of this subatrate ablation group and compared them with an historical control group undergoing conventional ablation.
Interventions
PROCEDURERoutine substrate ablation without pulmonary vein Isolation
PROCEDURERoutine conventional ablation with pulmonary vein Isolation
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient from 18 to 85, with AF\* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)\* \*In accordance with the recommendation of European Society of Cardiology (2010).
Exclusion criteria
* organized atrial activity (Atrial tachycardia or Flutter)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure | up to 240 min | percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiofrequency Time (Min) | up to 300 min | — |
| Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation | 18 Months post ablation | % of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up. |
| Number of Patients With Major Adverse Events During and up to 18 Months After Procedure | 18 months post ablation | Adverse events |
| % of Patients With Sinus Rhythm Conversion During the Procedure | 180 min | — |
| Mean LA Volume | baseline | Left Atrial volume before ablation in ml |
| Spontaneous AF at the Beginning of the Procedure | baseline | Spontaneous AF at the beginning of the procedure |
| Maximum Sustained AF Duration | from first AF episode to baseline | duration of the longest AF epiodes in months before ablation |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Substrate Ablation Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation. | 105 |
| Historical Control Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach | 47 |
| Total | 152 |
Baseline characteristics
| Characteristic | Substrate Ablation | Historical Control | Total |
|---|---|---|---|
| Age, Continuous | 63 year STANDARD_DEVIATION 11 | 58 year STANDARD_DEVIATION 11 | 61 year STANDARD_DEVIATION 13 |
| Diabetes | 13 participants | 5 participants | 18 participants |
| Hypertension | 48 participants | 20 participants | 68 participants |
| Nonparoxysmal AF | 81 participants | 38 participants | 119 participants |
| Paroxysmal AF | 24 participants | 9 participants | 33 participants |
| Sex: Female, Male Female | 25 Participants | 12 Participants | 37 Participants |
| Sex: Female, Male Male | 80 Participants | 35 Participants | 115 Participants |
| Structural heart disease | 38 participants | 14 participants | 52 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 47 |
| serious Total, serious adverse events | 1 / 105 | 0 / 47 |
Outcome results
Primary
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure
percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure
Time frame: up to 240 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substrate Ablation | Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure | 95 Percentage of participants |
| Historical Control | Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure | 60 Percentage of participants |
Secondary
Maximum Sustained AF Duration
duration of the longest AF epiodes in months before ablation
Time frame: from first AF episode to baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substrate Ablation | Maximum Sustained AF Duration | 12.2 months |
| Historical Control | Maximum Sustained AF Duration | 19.4 months |
Secondary
Mean LA Volume
Left Atrial volume before ablation in ml
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substrate Ablation | Mean LA Volume | 168 ml | Standard Deviation 45 |
Secondary
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure
Adverse events
Time frame: 18 months post ablation
Population: Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation.~Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substrate Ablation | Number of Patients With Major Adverse Events During and up to 18 Months After Procedure | 1 participants |
| Historical Control | Number of Patients With Major Adverse Events During and up to 18 Months After Procedure | 1 participants |
Secondary
% of Patients With Sinus Rhythm Conversion During the Procedure
Time frame: 180 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substrate Ablation | % of Patients With Sinus Rhythm Conversion During the Procedure | 71 % of participants |
| Historical Control | % of Patients With Sinus Rhythm Conversion During the Procedure | 26 % of participants |
Secondary
Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation
% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.
Time frame: 18 Months post ablation
Population: Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation.~Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substrate Ablation | Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation | 89 % of participants |
| Historical Control | Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation | 42 % of participants |
Secondary
Radiofrequency Time (Min)
Time frame: up to 300 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substrate Ablation | Radiofrequency Time (Min) | 49.1 min |
| Historical Control | Radiofrequency Time (Min) | 84.6 min |
Secondary
Spontaneous AF at the Beginning of the Procedure
Spontaneous AF at the beginning of the procedure
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substrate Ablation | Spontaneous AF at the Beginning of the Procedure | 65 Participants |