Arterial Embolism After Catheter Ablation of Atrial Fibrillation. ATRIAL FIBRILLATION
NCT ID: NCT06134739
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2024-01-02
2024-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)
NCT01361295
Anticoagulation in AF Ablation and Effects on Neurocognitive Function
NCT02120560
Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
NCT04761315
Atrial Fibrillation Ablation
NCT03410966
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
NCT04342312
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Arterial embolisms, particularly brain embolism (stroke or TIA) is one of the most clinically relevant complications of AFAbl procedures. According to the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE 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 1.006 (2.58%) 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 1.5% in the DECAAF trial, 0.4% 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 0.2% 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 0.6%.
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 stroke/TIA 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 stroke/TIA 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 stroke/TIA is more frequently associated to any AFAbl technique.
* To study whether the severity of stroke/TIA 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 stroke/TIA 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 - clinicaltrials.gov
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 Fisher's 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 Student's 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 \<0.1 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with embolism after ablation for atrial fibrillation (or left atrial flutter).
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.
No intervention.
Observational study, no intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention.
Observational study, no intervention.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The embolic event must be associated with the ablation procedure, therefore, it must have occurred during the procedure or during the first 7 days after it, during hospital stay or after discharge.
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.
UNKNOWN
Department of Rhythmology, University Hospital Schleswig-Holstein, Lübeck, Germany.
UNKNOWN
Hospital Universitario La Paz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Sergio Castrejón-Castrejón
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
José Luis Merino Llorens, MD PhD
Role: PRINCIPAL_INVESTIGATOR
La Paz University Hospital. Madrid. Spain.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Departmen of Cardiology, La Paz University Hospital
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI-5773
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.