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Left Atrial Appendage Closure During Open Heart Surgery

NCT02378116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2018-02-27

No results posted yet for this study

Summary

Because atrial fibrillation occurs frequently in heart surgery patients, our overall hypothesis is that systematic closing the left atrial appendage during surgery will reduce cerebral embolism coming from the thrombus formation in the left atrium.

The specific hypothesis which sought tested is that closure of the left atrial appendage in connection with elective CABG and / or valve surgery will lead to fewer strokes and micro cerebral infarcts measured by MRI.

Conditions

Interventions

PROCEDURE

Surgical closure of the left atrial appendage

When patients are randomized to surgical closure, the surgeon is informed to close the left appendage. Closure is documented by a member of the research group at the site.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Jesper P. Hansen, MD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-01-01
Completion
2017-01-01

Countries

  • Denmark

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 NCT02378116 on ClinicalTrials.gov