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

Completed

• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation; Renal Disease; Heart Diseases; Bleeding; Cardiovascular Diseases
• Interventions: Other: Non Intervention

• Registration Number: NCT03446794
• Lead Sponsor: Fundación EPIC

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-02-27
• Study Start: 2018-03-14
• Primary Completion: 2022-01-07
• Study Completion: 2022-01-07
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-19
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with NVAF and ESCKD on HD	Non Intervention	-

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality, stroke and bleeding	24 month	Composite: Stroke or Transient Ischemic Attack (TIA), Systemic embolism, Major bleeding event (BARC ≥ 2).; Systemic embolism, Major bleeding event (BARC ≥ 2)

Secondary Outcome Measures

Name	Time	Method
Periprocedural major adverse events	2 days	Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization)
Echocardiographic adverse events during follow up	24 month	Prevalence and severity of residual leak

Trial Locations

Locations (20)

Hospital de Vinalopó; 🇪🇸 Torrevieja, Alicante, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Santa Creu y Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital Juan Ramón Jiménez Huelva; 🇪🇸 Huelva, Spain

Hospital Universitario de León; 🇪🇸 León, Spain

Hospital Universitario de Gran Canaria Dr. Negrín; 🇪🇸 Las Palmas de Gran Canaria, Spain

Hospital Clínico Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de Arrixaca; 🇪🇸 Murcia, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital Clínico Universitario Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain