Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention. The aim of the study is to assess the procedural safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial fibrillation (NVAF) and ESCKD on HD.
Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention.
Study Type
OBSERVATIONAL
Enrollment
300
To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD
Hospital de Vinalopó
Torrevieja, Alicante, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Santa Creu y Sant Pau
Barcelona, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital Juan Ramón Jiménez Huelva
Huelva, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
...and 10 more locations
Composite of all-cause mortality, stroke and bleeding
Composite: Stroke or Transient Ischemic Attack (TIA), Systemic embolism, Major bleeding event (BARC ≥ 2). Systemic embolism, Major bleeding event (BARC ≥ 2)
Time frame: 24 month
Periprocedural major adverse events
Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization)
Time frame: 2 days
Echocardiographic adverse events during follow up
Prevalence of device thrombus
Time frame: 24 month
Echocardiographic adverse events during follow up
Prevalence and severity of residual leak
Time frame: 24 month
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