Investigating arterial embolism after catheter ablation for atrial fibrillation
"Arterial EMBOLism After Catheter Ablation of Atrial Fibrillation (EMBOL AF)"
Hospital Universitario La Paz · NCT06134739
This study looks at how often strokes and other blood clots happen after a heart procedure called catheter ablation for people with atrial fibrillation to better understand these risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Hospital Universitario La Paz (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06134739 on ClinicalTrials.gov |
What this trial studies
The EMBOL-AF is a multicenter, international observational study that aims to analyze the characteristics of systemic arterial embolic events following catheter ablation for atrial fibrillation. This retrospective registry will focus on cerebral embolisms, particularly strokes and transient ischemic attacks (TIAs), which are significant complications of the procedure. Data will be collected from various centers regarding all cases of arterial embolism that occurred over the past five years, allowing for an assessment of incidence, management, and outcomes related to these events. The study seeks to address the underreporting of such complications and provide a clearer understanding of their frequency and impact.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have experienced systemic arterial embolism, such as stroke or TIA, following catheter ablation for atrial fibrillation or related conditions within the specified timeframe.
Not a fit: Patients whose embolic events can be clearly attributed to other causes unrelated to the ablation procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and reduced incidence of embolic events in patients undergoing catheter ablation for atrial fibrillation.
How similar studies have performed: Other studies have reported varying incidences of embolic events after catheter ablation, indicating that while this area has been explored, the specific focus on comprehensive data collection in a multicenter registry is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Madrid
- Departmen of Cardiology, La Paz University Hospital — Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: José Luis Merino Llorens, MD PhD — La Paz University Hospital. Madrid. Spain.
- Study coordinator: Sergio Castrejón Cstrejón, MD PhD
- Email: castrejonxp@gmail.com
- Phone: +34 941 207 13 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arrhythmia, Atrial Fibrillation, Ablation, Stroke, Acute, Stroke Sequelae, Embolism, Atrial fibrillation., Catheter ablation.