Preventing Neurologic Complications in Valve Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of prior cardiac surgery

history of cerebral infarction (ischemic stroke)

emergency surgery

infective endocarditis

Trial design

Treatments tested in this trial

  • Left Atrial Appendage (LAA) Suture Closure
  • Surgical Valve Surgery

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

4
Fuwai Hospital Chinese Academy of Medical Sciences BeijingBeijing Municipality, China
Peking University First Hospita BeijingBeijing Municipality, China
Qingdao Cardiovascular Hospital Qingdao China
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen Shenzhen China

Sponsors and collaborators

China National Center for Cardiovascular Diseases

Lead sponsor