The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

December 7, 2023 updated by: Beshoy Allam Moris, Assiut University

The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery Irrespective of Preoperative Atrial Fibrillation Status and Stroke Risk.

This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebrovascular complications following cardiac surgical procedures are a significant source of morbidity and mortality. The etiology of postoperative stroke is multifactorial and may include carotid artery stenosis, hypotension, cardiac arrhythmia, aortic atherosclerosis, and transient hypercoagulable state.

Most strokes complicating cardiac surgery occur in patients without significant carotid disease and are acquired after the patient awakens neurologically intact. The high incidence of postoperative AF in these patients suggests a possible embolic cause for some strokes. As such, some postoperative strokes may be preventable.

Previous studies report incident AF in 10 to 65% of patients after open heart surgery, with the highest incidences after a combination of coronary artery bypass grafting (CABG) and valve surgery.

In patients with non-operative AF, the risk of ischemic stroke is markedly reduced by adequate OAC. However, the management of postoperative AF is still a challenge and is, by some, regarded as a transient phenomenon not requiring intervention. The risk of bleeding poses a significant limitation to the use of OAC, which consequently increases focus on left atrial appendage (LAA) closure, as the LAA is a predilection site for thrombus formation during AF.

Based on previous studies, ≥90% of AF-related left atrial thrombi are located in the left atrial appendage (LAA), and therefore, LAA occlusion is a tempting method for AF-related stroke prevention.

Current recommendations regarding surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years scheduled for first-time planned open-heart surgery.

Exclusion Criteria:

Pediatric population >18 years. Emergent open heart surgery. Patients with current endocarditis. Where follow-up is not possible. The patient refused to sign the informed consent to participate in the research.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A.
surgical closure of the left atrial appendage.
Procedure: the left atrial appendage closure through surgery.
Surgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled.
Other Names:
  • LAACS
No Intervention: group B.
There was no surgical closure of the left atrial appendage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke.
Time Frame: 2 years post operative.
the incidence of stroke in patients undergoing open-heart surgery, including transient ischemic attack, as assigned by two independent neurologists blinded to the treatment allocation.
2 years post operative.
Mortality
Time Frame: 2 years post operative.
post-operative mortality rate.
2 years post operative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative arrhythmias.
Time Frame: 1 year
Incidence of postoperative arrhythmias with special regard to post-operative AF.
1 year
Hospital stay.
Time Frame: 1 month
Number of inpatient hospital stay days.
1 month

Collaborators and Investigators

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

Sponsor

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Left atrial appendage closure.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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