Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease

NCT02039167 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-11-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the superiority of left atrial appendage occlusion in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the frequency of occurrence of at least one bleeding classified as moderate or major within 24 months.

Conditions

  • Blood Coagulation Disorders
  • Atrial Fibrillation
  • Thrombosis of Left Atrial Appendage
  • Chronic Kidney Disease Stage 4
  • Chronic Kidney Disease Stage 5

Interventions

DEVICE

Left atrial appendage occlusion

Percutaneous left atrial appendage closure using the WATCHMAN device.

Sponsors & Collaborators

  • University of Magdeburg

    lead OTHER

Principal Investigators

  • Rüdiger C Braun-Dullaeus, Prof · Otto-von-Guericke University Magdeburg Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-03-21
Completion
2017-04-12

Countries

  • Germany

Study Locations

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Entities

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 NCT02039167 on ClinicalTrials.gov