Clinical trial NCT03446794: Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis
Official title: Registry of Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Heart Diseases
Renal Disease
Bleeding
Arrhythmias, Cardiac
Cardiovascular Diseases
Keywords: Left Atrial Appendage Closure
Watchman device
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of all-cause mortality, stroke and bleeding
timeFrame: 24 month
Secondary outcomes:
measure: Periprocedural major adverse events
timeFrame: 2 days
measure: Echocardiographic adverse events during follow up
timeFrame: 24 month
measure: Echocardiographic adverse events during follow up
timeFrame: 24 month
Other outcomes:
Locations:
city: Torrevieja
country: Spain
facility: Hospital de Vinalopó
state: Alicante
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu y Sant Pau
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez Huelva
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrín
city: León
country: Spain
facility: Hospital Universitario de León
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References:
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