MedTrace Logo

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

NCT03446794 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-06-24

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2022-01-07
Completion
2022-01-07

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446794 on ClinicalTrials.gov