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Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation

NCT02426944 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-06-11

No results posted yet for this study

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The source of a cardioembolic event is a thrombus, which usually forms in the left atrial appendage (LAA). The prevention of cardioembolic events involves treatment with anticoagulant drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin). Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can be life threatening. Recently, two new options for thrombus prevention have been developed. The first is the novel anticoagulants (NOAC), which were associated with slightly better safety profiles due to a lower frequency of intracranial bleeding in large randomized trials . The second option involves interventional occlusion of the LAA. The aim of this project is to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized multicenter study of AF patients at high risk of a cardioembolic event.

Conditions

Interventions

DRUG

NOAC

Medical arm, patients will be treated by NOAC.

DEVICE

Left atrial appendage closure

The patients will be treated by interventional closure of the left atrial appendage.

Sponsors & Collaborators

  • Ministry of Health, Czech Republic

    collaborator OTHER_GOV

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2019-07-20
Completion
2019-07-20

Countries

  • Czechia

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 NCT02426944 on ClinicalTrials.gov