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NCT Number: NCT03446794

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Bleeding Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hemorrhage Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Disease Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Vinalopó, Torrevieja, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non intervention

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Periprocedural major adverse events

    Time frame: 2 days

    Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization)

  2. Echocardiographic adverse events during follow up

    Time frame: 24 month

    Prevalence of device thrombus

  3. Echocardiographic adverse events during follow up

    Time frame: 24 month

    Prevalence and severity of residual leak

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study 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

Acronym: WATCH-HD

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2018
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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