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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Studied | 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 |
| |
| Control | The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine substrate ablation without pulmonary vein Isolation | Procedure |
| ||
| Routine conventional ablation with pulmonary vein Isolation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 240 min |
| Measure | Description | Time Frame |
|---|---|---|
| % of Patients With Sinus Rhythm Conversion During the Procedure | 180 min | |
| Radiofrequency Time (Min) | up to 300 min | |
| Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Julien Seitz, MD | St Joseph hospital Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Joseph | Marseille | 13008 | France | |||
| CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28104073 | Derived | Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Substrate Ablation | Between September 2013 and July 2014, 105 patients with AF were prospectively enrolled at three centers performing substrate ablation (without pulmonary vein isolation) routinely |
| FG001 | Historical Control | The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Historical Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | Posted | Number | Percentage of participants | up to 240 min |
|
from ablation to 18 month follow up
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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 | Substrate Ablation | Study population (n=105) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redo Pericardial effusion | Cardiac disorders | occuring few months after initial ablation during second ablation procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Julien Seitz | Saint joseph hospital | +330491807044 | jseitz@hopital-saint-joseph.fr |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Procedure |
|
% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up. |
| 18 Months post ablation |
| Number of Patients With Major Adverse Events During and up to 18 Months After Procedure | Adverse events | 18 months post ablation |
| Maximum Sustained AF Duration | duration of the longest AF epiodes in months before ablation | from first AF episode to baseline |
| Mean LA Volume | Left Atrial volume before ablation in ml | baseline |
| Spontaneous AF at the Beginning of the Procedure | Spontaneous AF at the beginning of the procedure | baseline |
| Nice |
| France |
| Institut Mutualiste de Montsouris | Paris | France |
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 |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Paroxysmal AF | Number | participants |
|
| Nonparoxysmal AF | Number | participants |
|
| Structural heart disease | Number | participants |
|
| Hypertension | Number | participants |
|
| Diabetes | Number | participants |
|
|
|
| Secondary | % of Patients With Sinus Rhythm Conversion During the Procedure | Posted | Number | % of participants | 180 min |
|
|
|
| Secondary | Radiofrequency Time (Min) | Posted | Number | min | up to 300 min |
|
|
|
| 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. | 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) | Posted | Number | % of participants | 18 Months post ablation |
|
|
|
| Secondary | Number of Patients With Major Adverse Events During and up to 18 Months After Procedure | Adverse events | 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) | Posted | Number | participants | 18 months post ablation |
|
|
|
| Secondary | Maximum Sustained AF Duration | duration of the longest AF epiodes in months before ablation | Posted | Number | months | from first AF episode to baseline |
|
|
|
| Secondary | Mean LA Volume | Left Atrial volume before ablation in ml | Posted | Mean | Standard Deviation | ml | baseline |
|
|
|
| Secondary | Spontaneous AF at the Beginning of the Procedure | Spontaneous AF at the beginning of the procedure | Posted | Count of Participants | Participants | baseline |
|
|
|
| 1 |
| 105 |
| 0 |
| 105 |
| EG001 | Historical Control | Validation set (n=47) | 0 | 47 | 0 | 47 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |