Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134739
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-10-30
Brief Title:
Arterial Embolism After Catheter Ablation of Atrial Fibrillation ATRIAL FIBRILLATION
Sponsor:
Hospital Universitario La Paz
Organization:
Hospital Universitario La Paz
Study Overview
Official Title:
Arterial EMBOLism After Catheter Ablation of Atrial Fibrillation EMBOL AF
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBOL-AF
Brief Summary:
The EMBOL-AF is a multicenter international observational study designed as a retrospective registry that will investigate the characteristics of systemic arterial embolic events after treatment of atrial fibrillation by catheter ablation Due to the retrospective nature of the study the registry is specially focused on cerebral embolism stroke and TIA because these are not only the most frequent and clinically relevant but also the most susceptible to underreporting However all embolism associated to AFAbl will be included
This study will gather all clinically relevant aspects and data of all cases of arterial embolism that have occurred over the last 5 years in the centers that will participate in the registry Based on these reported cases the incidence management and outcomes of embolic events particularly stroke and TIA will be studied
This study will gather all clinically relevant aspects and data of all cases of arterial embolism that have occurred over the last 5 years in the centers that will participate in the registry Based on these reported cases the incidence management and outcomes of embolic events particularly stroke and TIA will be studied
Detailed Description:
BACKGROUND
Arterial embolisms particularly brain embolism stroke or TIA is one of the most clinically relevant complications of AFAbl procedures According to the 2017 HRSEHRAECASAPHRSSOLAECE consensus the incidence is reported to be very variable 0-7 and the high-risk period extends for the first two weeks following ablation A strict management of uninterrupted oral anticoagulation and an intraprocedural activated clotting time ACT target 300 s along with careful use of imaging techniques to rule out interatrial thrombus and high-flow perfusion of sheaths placed in the heart are necessary measures to reduce the incidence of this complication However the real incidence of periprocedural stroke TIA remains high as exemplified by the results of the CABANA trial where 26 out of 1006 258 patients in the ablation group who actually underwent ablation had stroke or TIA More recently the incidence of stroke when extensive ablation in the LA in addition to the PVI ablation has been 15 in the DECAAF trial 04 in the STABLE-SR II trial and 0 in the ERASE-AF trial The Spanish Catheter Ablation Registry has reported an incidence of stroke of 02 in 2020 and 2021 but these numbers may be underestimated due to the voluntary self-reported data collection of this registry In another population-based registry the incidence of stroke among octogenarian patients after AFAbl was 06
Although the relevance of this complication is well established in terms of incidence and clinical impact two critical aspects remain insufficiently investigated Firstly little is known about the acute clinical characteristics therapeutic management and sequelae of stroke or TIA after AFABl Secondly the occurrence of strokeTIA might be more frequent with certain ablation techniques The widespread use of newer ablation techniques in the last years such as different modalities of cryoablation laser ablation and pulsed-field ablation may influence the incidence or severity of embolic events In consequence a large international registry is justified to further clarify these less known aspects
The EMBOL-AF is a multicenter international observational study designed as a retrospective registry that will investigate the characteristics of systemic arterial embolic events after treatment of atrial fibrillation by catheter ablation Due to the retrospective nature of the study the registry is specially focused on cerebral embolism stroke and TIA because these are not only the most frequent and clinically relevant but also the most susceptible to underreporting However all embolism associated to AFAbl will be included
This study will gather all clinically relevant aspects and data of all cases of arterial embolism that have occurred over the last 5 years in the centers that will participate in the registry Based on these reported cases the incidence management and outcomes of embolic events particularly stroke and TIA will be studied
OBJECTIVES
Primary objectives
To study the acute clinical profile symptoms signs and results of image techniques of strokeTIA associated to AFAbl or technically akin procedures such as left atrial macroreentry mapping and ablation
To study the acute therapeutic management of these events
To study the sequelae and clinical consequences at 3 months of follow-up
Secondary objectives
To study whether the risk of strokeTIA is more frequently associated to any AFAbl technique
To study whether the severity of strokeTIA is associated to any specific AFAbl technique
To study whether other measures associated with AFAbl procedures have any impact on the incidence and severity of strokeTIA namely transesophageal echocardiography discontinuance of oral anticoagulants target intraprocedural anticoagulation and use of general anesthesia
Primary and secondary objectives are applicable to other symptomatic systemic arterial embolic events
DESIGN OVERVIEW
1 -Intervention model not applicable single retrospective cohort
2 -Control not applicable
3 -Active comparator not applicable
4 -Number of arms one
5 -Site distribution multi-regional
6 -Population type patients who have undergone catheter AFAbl
7 -Population diagnosis or condition stroke or TIA after AFAbl other systemic arterial embolism will be be included
8 -Population age 18 years
9 -Blinding not applicable
10 -Number of participants not predefined all consecutive patients fulfilling inclusion criteria during the period of study
11 -Period of the study last 5 years retrospectively
SCHEDULE OF ACTIVITIES
1 -Approval of the protocol by the steering committee and by the local ethical review board of La Paz University Hospital - IdiPaz Madrid España The study has been registered with the international registry - clinicaltrialsgov
2 -Invitation to centers experienced electrophysiological centers all around the world and principal local investigators will be formally contacted and personally invited to participate in the study
3 -Initial survey by center the initial survey will gather general information about centers
4 -Local approval of the protocol in each participating center
5 -Retrospective collection of data
6 -Final collection of general information about the reference population in each center Each participating center will provides data on the total number of patients treated with catheter ablation for AF during the period of study
CHRONOLOGY
The EMBOL-AF international registry is expected to start during the fourth quarter of the year 2023 Maximal time for data collection will be 6 months Maximal time for data monitoring will be 6 months
LIMITATIONS
The retrospective design of the study may involve underreporting of cases and the severity of reported cases may be biased by severity This bias may specially affect to embolic events other than stroke and TIA Treatment of cerebral embolisms may be undertake in hospitals different to the participating center where the complication occurred and this could lead to data losses or inconsistencies
DATA STORAGE AND MANAGEMENT
Each participating center will provide data on a survey about its habitual practices of catheter ablation for atrial fibrillation Appendix 2 Additionally each center will provide data on the total number of patients treated with catheter ablation during the retrospective period of study Appendix 3 These data are used to contextualize the data of individual reported patients Appendix 4 Individual patient data include baseline characteristics peri-procedural characteristics and 3-months follow-up after ablation All data will be assessed according to a standardized and uniform online questionnaire survey online DCL data collection logbook
1 -Collection of data The principal investigator in each center is responsible for collecting the data and must assess and declare the veracity of them All data are anonymized The retrospective data derived from the routine clinical histories and medical reports will be used in each center
2 -Storage of data An online DCL is used to this end The online DCL has been designed and is under direct supervision and monitoring by the UCICEC Red CAP All investigators are obliged to secrecy In consequence only the local IP is permitted to access the data using a personal keyword Any unauthorized external access to the data is forbidden
Confidentiality of data is guaranteed by legal enforcement
STATISTICS
All categorical variables will be reported as absolute and relative frequencies or percentages and will be compared using Fishers exact test or the χ2 test Continuous variables will be tested for normal distribution using the Shapiro-Wilk test as well as analysis of residuals of linear regression models The results will be reported in a way that is most informative in each case as mean standard deviation SD in the case of normal distribution or as median and interquartile range first quartile third quartile Continuous variables will be compared using the non-paired Students t-test when normally distributed and the corresponding non-parametric test Mann-Whitney U test otherwise
The association between different parameters and embolic event occurrence will be assessed using binary logistic regression and reported as odds ratio OR and 95 confidence intervals CIs
Variables with a P-value 01 in the univariate model and which are considered clinically important for the outcome are included in a multivariable binary logistic regression model
All statistical analyses will be performed using the last version of R software of statistical analysis
ETHICS
The study has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments
Due to the retrospective desing of the study a specific written informed consent cannot be obtained from patients
Arterial embolisms particularly brain embolism stroke or TIA is one of the most clinically relevant complications of AFAbl procedures According to the 2017 HRSEHRAECASAPHRSSOLAECE consensus the incidence is reported to be very variable 0-7 and the high-risk period extends for the first two weeks following ablation A strict management of uninterrupted oral anticoagulation and an intraprocedural activated clotting time ACT target 300 s along with careful use of imaging techniques to rule out interatrial thrombus and high-flow perfusion of sheaths placed in the heart are necessary measures to reduce the incidence of this complication However the real incidence of periprocedural stroke TIA remains high as exemplified by the results of the CABANA trial where 26 out of 1006 258 patients in the ablation group who actually underwent ablation had stroke or TIA More recently the incidence of stroke when extensive ablation in the LA in addition to the PVI ablation has been 15 in the DECAAF trial 04 in the STABLE-SR II trial and 0 in the ERASE-AF trial The Spanish Catheter Ablation Registry has reported an incidence of stroke of 02 in 2020 and 2021 but these numbers may be underestimated due to the voluntary self-reported data collection of this registry In another population-based registry the incidence of stroke among octogenarian patients after AFAbl was 06
Although the relevance of this complication is well established in terms of incidence and clinical impact two critical aspects remain insufficiently investigated Firstly little is known about the acute clinical characteristics therapeutic management and sequelae of stroke or TIA after AFABl Secondly the occurrence of strokeTIA might be more frequent with certain ablation techniques The widespread use of newer ablation techniques in the last years such as different modalities of cryoablation laser ablation and pulsed-field ablation may influence the incidence or severity of embolic events In consequence a large international registry is justified to further clarify these less known aspects
The EMBOL-AF is a multicenter international observational study designed as a retrospective registry that will investigate the characteristics of systemic arterial embolic events after treatment of atrial fibrillation by catheter ablation Due to the retrospective nature of the study the registry is specially focused on cerebral embolism stroke and TIA because these are not only the most frequent and clinically relevant but also the most susceptible to underreporting However all embolism associated to AFAbl will be included
This study will gather all clinically relevant aspects and data of all cases of arterial embolism that have occurred over the last 5 years in the centers that will participate in the registry Based on these reported cases the incidence management and outcomes of embolic events particularly stroke and TIA will be studied
OBJECTIVES
Primary objectives
To study the acute clinical profile symptoms signs and results of image techniques of strokeTIA associated to AFAbl or technically akin procedures such as left atrial macroreentry mapping and ablation
To study the acute therapeutic management of these events
To study the sequelae and clinical consequences at 3 months of follow-up
Secondary objectives
To study whether the risk of strokeTIA is more frequently associated to any AFAbl technique
To study whether the severity of strokeTIA is associated to any specific AFAbl technique
To study whether other measures associated with AFAbl procedures have any impact on the incidence and severity of strokeTIA namely transesophageal echocardiography discontinuance of oral anticoagulants target intraprocedural anticoagulation and use of general anesthesia
Primary and secondary objectives are applicable to other symptomatic systemic arterial embolic events
DESIGN OVERVIEW
1 -Intervention model not applicable single retrospective cohort
2 -Control not applicable
3 -Active comparator not applicable
4 -Number of arms one
5 -Site distribution multi-regional
6 -Population type patients who have undergone catheter AFAbl
7 -Population diagnosis or condition stroke or TIA after AFAbl other systemic arterial embolism will be be included
8 -Population age 18 years
9 -Blinding not applicable
10 -Number of participants not predefined all consecutive patients fulfilling inclusion criteria during the period of study
11 -Period of the study last 5 years retrospectively
SCHEDULE OF ACTIVITIES
1 -Approval of the protocol by the steering committee and by the local ethical review board of La Paz University Hospital - IdiPaz Madrid España The study has been registered with the international registry - clinicaltrialsgov
2 -Invitation to centers experienced electrophysiological centers all around the world and principal local investigators will be formally contacted and personally invited to participate in the study
3 -Initial survey by center the initial survey will gather general information about centers
4 -Local approval of the protocol in each participating center
5 -Retrospective collection of data
6 -Final collection of general information about the reference population in each center Each participating center will provides data on the total number of patients treated with catheter ablation for AF during the period of study
CHRONOLOGY
The EMBOL-AF international registry is expected to start during the fourth quarter of the year 2023 Maximal time for data collection will be 6 months Maximal time for data monitoring will be 6 months
LIMITATIONS
The retrospective design of the study may involve underreporting of cases and the severity of reported cases may be biased by severity This bias may specially affect to embolic events other than stroke and TIA Treatment of cerebral embolisms may be undertake in hospitals different to the participating center where the complication occurred and this could lead to data losses or inconsistencies
DATA STORAGE AND MANAGEMENT
Each participating center will provide data on a survey about its habitual practices of catheter ablation for atrial fibrillation Appendix 2 Additionally each center will provide data on the total number of patients treated with catheter ablation during the retrospective period of study Appendix 3 These data are used to contextualize the data of individual reported patients Appendix 4 Individual patient data include baseline characteristics peri-procedural characteristics and 3-months follow-up after ablation All data will be assessed according to a standardized and uniform online questionnaire survey online DCL data collection logbook
1 -Collection of data The principal investigator in each center is responsible for collecting the data and must assess and declare the veracity of them All data are anonymized The retrospective data derived from the routine clinical histories and medical reports will be used in each center
2 -Storage of data An online DCL is used to this end The online DCL has been designed and is under direct supervision and monitoring by the UCICEC Red CAP All investigators are obliged to secrecy In consequence only the local IP is permitted to access the data using a personal keyword Any unauthorized external access to the data is forbidden
Confidentiality of data is guaranteed by legal enforcement
STATISTICS
All categorical variables will be reported as absolute and relative frequencies or percentages and will be compared using Fishers exact test or the χ2 test Continuous variables will be tested for normal distribution using the Shapiro-Wilk test as well as analysis of residuals of linear regression models The results will be reported in a way that is most informative in each case as mean standard deviation SD in the case of normal distribution or as median and interquartile range first quartile third quartile Continuous variables will be compared using the non-paired Students t-test when normally distributed and the corresponding non-parametric test Mann-Whitney U test otherwise
The association between different parameters and embolic event occurrence will be assessed using binary logistic regression and reported as odds ratio OR and 95 confidence intervals CIs
Variables with a P-value 01 in the univariate model and which are considered clinically important for the outcome are included in a multivariable binary logistic regression model
All statistical analyses will be performed using the last version of R software of statistical analysis
ETHICS
The study has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments
Due to the retrospective desing of the study a specific written informed consent cannot be obtained from patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None