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

July 14, 2020 updated by: Mohamed Osman Abdelhamead, Assiut University

Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients selection All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.

Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.

Methods In this retrospective cohort study

  1. All patients with previous major bleeding or a bleeding predisposition scheduled for transcatheter LAAC in Assiut university in the period from January 2014 to December 2019 will be included.
  2. All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT and Lambre)
  3. CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.
  4. 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.
  5. Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.
  6. New York Heart Association (NYHA) classification will be determined for all patient graded from I-IV.
  7. Both groups will be compared regarding procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, major and minor bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up.
  8. Device related thrombus (DRT) will be compared in both groups according to the results of transesophageal echo (TOE) 6 weeks post procedure.

Primary endpoint

- The primary endpoints of the study are procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up in both groups of patients with heart failure and without heart failure.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.

In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants who were scheduled for transcatheter left atrial appendage closure are included

Description

Inclusion Criteria:

  • In this study,

    1. Atrial fibrillation patients with previous major bleeding.
    2. Atrial fibrillation patients with previous bleeding predisposition
    3. Atrial fibrillation patients with previous contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.

Exclusion Criteria:

  • Patients having no data for follow up after the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with atrial fibrillation and heart failure
Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study
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.
patients with atrial fibrillation without heart failure
Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedural success
Time Frame: 6 weeks post procedure
procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm) The study will assess the rate of procedural success in both groups of the study.
6 weeks post procedure
the absence of any complication related to the intervention
Time Frame: 6 months post intervention
Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.
6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohamed A Osman, Ass. lect., Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2020

Primary Completion (Anticipated)

March 15, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAA closure in heart failure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Device Occlusion

Clinical Trials on Left atrial appendage closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe