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

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.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06172738
Enrollment
100
Registered
2023-12-15
Start date
2024-01-01
Completion date
2027-12-30
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Atrial Appendage Thrombosis

Keywords

surgical closure of the left atrial appendage., stroke, Post operative atrial fibrillation.

Brief summary

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.

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.

Interventions

PROCEDUREthe 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double blinded.

Intervention model description

Randomized control trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stroke.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.
Mortality2 years post operative.post-operative mortality rate.

Secondary

MeasureTime frameDescription
Postoperative arrhythmias.1 yearIncidence of postoperative arrhythmias with special regard to post-operative AF.
Hospital stay.1 monthNumber of inpatient hospital stay days.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026