Preventing Neurologic Complications in Valve Surgery

National Center for Cardiovascular Diseases

Status

Not yet enrolling

Conditions

Left Atrial Appendage Closure

Treatments

Procedure: Surgical Valve Surgery

Procedure: Left Atrial Appendage (LAA) Suture Closure

Study type

Observational

Funder types

Other

Identifiers

NCT07382362

2024-2452

Details and patient eligibility

About

In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative thromboembolic events, particularly neurologic embolic events. However, whether concomitant LAA management benefits patients without AF by reducing postoperative neurologic complications remains controversial.

Given these uncertainties, this study aims to evaluate whether concomitant LAA suture closure during surgical valve surgery is associated with a lower incidence of perioperative silent cerebral infarction.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo open (direct-vision) surgical heart valve surgery and who are informed about the study and provide written informed consent to participate.

Exclusion criteria

History of prior cardiac surgery
history of cerebral infarction (ischemic stroke)
emergency surgery
infective endocarditis
pregnancy
refusal or inability to provide informed consent/declines participation in this study.