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

Last updated: June 19, 2022
Sponsor: Fundación EPIC
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Renal Failure

Treatment

N/A

Clinical Study ID

NCT03446794
WATCH-HD EPIC-06
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age> 18 years.
  • Stage V chronic kidney disease (GFR <15 ml / min) in hemodialysis at the time of leftatrial appendage closure.
  • History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
  • Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy dueto 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 providedwritten informed consent.

Exclusion

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

Total Participants: 300
Study Start date:
March 14, 2018
Estimated Completion Date:
January 07, 2022

Study 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.

Connect with a study center

  • Hospital de Vinalopó

    Torrevieja, Alicante 03293
    Spain

    Site Not Available

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Site Not Available

  • Hospital Costa del Sol

    Marbella, Málaga 29603
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Santa Creu y Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009
    Spain

    Site Not Available

  • Hospital Juan Ramón Jiménez Huelva

    Huelva, 21005
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaén

    Jaén, 23007
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario de León

    León, 24071
    Spain

    Site Not Available

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, 33011
    Spain

    Site Not Available

  • Clínica Universitaria de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

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