Arterial Embolism After Catheter Ablation of Atrial Fibrillation. ATRIAL FIBRILLATION

NCT06134739 | Unknown

• 1 other identifier: PI-5773
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia; Atrial Fibrillation; Ablation; Stroke, Acute; Stroke Sequelae; Embolism

Keywords

Atrial fibrillation.; Catheter ablation.; Stroke.; Procedure complication.; Embolism.; Anticoagulation.

Outcome Measures

Primary Outcomes (4)

• Stroke

  To study the acute clinical profile of stroke/TIA associated to AFAbl (or technically akin procedures such as left atrial macroreentry mapping and ablation).stroke/TIA associated to AFAbl (or technically akin procedures such as left atrial macroreentry mapping and ablation).

  Between 1st january 2017 and 31st july 2023.

• Stroke

  To study the results of brain image techniques of stroke/TIA associated to AFAbl (or technically akin procedures such as left atrial macroreentry mapping and ablation).procedures such as left atrial macroreentry mapping and ablation).stroke/TIA associated to AFAbl (or technically akin procedures such as left atrial macroreentry mapping and ablation).

  Between 1st january 2017 and 31st july 2023.

• Management of arterial embolism.

  To study the acute therapeutic management of these events.

  Between 1st january 2017 and 31st july 2023.

• Sequelae

  To study the sequelae and clinical consequences at 3 months of follow-up.

  Between 1st january 2017 and 31st july 2023.

Secondary Outcomes (2)

• To study whether the severity of stroke/TIA is associated to any specific ablation techniques.

  Between 1st january 2017 and 31st july 2023.

• To study other procedure-related aspects as predictors of stroke/TIA.

  Between 1st january 2017 and 31st july 2023.

Other Outcomes (2)

• To study if the incidence of peripheral embolic events is associated to specific ablation techniques.

  Between 1st january 2017 and 31st july 2023.

• To study other procedure-related aspects as predictors of peripheral embolism.

  Between 1st january 2017 and 31st july 2023.

Study Arms (1)

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.

Other: No intervention.

Interventions

No intervention. OTHER

Observational study, no intervention.

Also known as: Observational study, no intervention.

Patients with embolism after ablation for atrial fibrillation (or left atrial flutter).

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Site distribution: multi-regional. * Population type: patients who have undergone catheter AFAbl. * Population diagnosis or condition: stroke or TIA after AFAbl; other systemic arterial embolism will be be included. * Population age: \>18 years. * Blinding: not applicable. * Period of the study: last 5 years, retrospectively.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• 3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.: collaborator
• Department of Rhythmology, University Hospital Schleswig-Holstein, Lübeck, Germany.: collaborator

Study Sites (1)

Departmen of Cardiology, La Paz University Hospital

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Stroke; Embolism

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• José Luis Merino Llorens, MD PhD

  La Paz University Hospital. Madrid. Spain.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Castrejón Cstrejón, MD PhD

CONTACT

+34 941 207 13 01; castrejonxp@gmail.com

Beatriz Sanz Verdejo, Engineer

CONTACT

+34 941 207 13 01; embolaf.registry@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 18, 2023
• Study Start: January 2, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)