Arterial Embolism After Catheter Ablation of Atrial Fibrillation. ATRIAL FIBRILLATION (NCT06134739) | Clinical Trial Compass
UnknownNot Applicable
Arterial Embolism After Catheter Ablation of Atrial Fibrillation. ATRIAL FIBRILLATION
Spain500 participantsStarted 2024-01-02
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Systemic arterial embolism (stroke, TIA or any other symptomatic event) after catheter ablation for AF or left atrial macroreentrant atrial tachycardia or left atrial flutter that have occurred between 1st january 2017 and 31st july 2023.
* 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:
* The embolic event that occurred during the first 7 days after the ablation procedure can be undoubtedly attributed to other causes, such as surgery (cardiac, aortic or carotidal) or percutaneous interventions (coronary, cardiac structural, aortic or carotidal).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stroke
Timeframe: Between 1st january 2017 and 31st july 2023.
2
Stroke
Timeframe: Between 1st january 2017 and 31st july 2023.
3
Management of arterial embolism.
Timeframe: Between 1st january 2017 and 31st july 2023.
4
Sequelae
Timeframe: Between 1st january 2017 and 31st july 2023.