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

June 19, 2022 updated by: Fundación EPIC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08041
        • Hospital Santa Creu Y Sant Pau
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta del Mar
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jiménez Huelva
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr. Negrin
      • León, Spain, 24071
        • Hospital Universitario de Leon
      • Madrid, Spain, 28040
        • Hospital Clínico Universitario San Carlos
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de Arrixaca
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Pamplona, Spain, 31008
        • Clinica Universitaria De Navarra
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Santiago De Compostela, Spain, 15706
        • Hospital Clinico Universitario Santiago de Compostela
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen De La Macarena
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Alicante
      • Torrevieja, Alicante, Spain, 03293
        • Hospital de Vinalopó
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Hospital Costa del Sol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with NVAF and ESCKD on HD
Other: Non Intervention
To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD
Other Names:
  • Safety and efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of all-cause mortality, stroke and bleeding
Time Frame: 24 month

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2018

Primary Completion (Actual)

January 7, 2022

Study Completion (Actual)

January 7, 2022

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WATCH-HD EPIC-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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