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

Fundación EPIC

Status: Completed

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

Treatments: Other: Non Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03446794

WATCH-HD EPIC-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

patients with NVAF and ESCKD on HD

Treatment:

Other: Non Intervention