Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Registry of Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

Conditions
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Atrial Fibrillation, Heart Diseases, Renal Disease, Bleeding, Arrhythmias, Cardiac, Cardiovascular Diseases

Intervention / Treatment
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* Other: Non Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years. Stage V chronic kidney disease (GFR <15 ml / min) in hemodialysis at the time of left atrial appendage closure. History of atrial or valvular fibrillation (paroxysmal, persistent, permanent). Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation. High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC> 2). The patient has been informed of the characteristics of the study and has provided written informed consent. Exclusion Criteria: Life expectancy < 2 years. Indication for OA different from NVAF. Severe pericardial effusion. Previous percutaneous closure of atrial septal defect. Intracardiac thrombus. Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) > 1.5. The patient refuses to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with NVAF and ESCKD on HD<br> | Other: Non Intervention<br>* To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD<br>* Other names: Safety and efficacy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural major adverse events | Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization) | 2 days | 
| Echocardiographic adverse events during follow up | Prevalence of device thrombus | 24 month | 
| Echocardiographic adverse events during follow up | Prevalence and severity of residual leak | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Watchman device, Left Atrial Appendage Closure