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Feasibility and Prognosis of Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation

NCT04472871 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-07-16

No results posted yet for this study

Summary

Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed even on oral anticoagulants.

Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with heart failure in preventing thromboembolic events, bleeding and all-cause mortality.

Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.

Conditions

  • Device Occlusion

Interventions

DEVICE

Left atrial appendage closure

The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed A Osman, Ass. lect. · Assiut University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2021-03-15
Completion
2021-07-01
FDA Device
Yes

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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 NCT04472871 on ClinicalTrials.gov