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NCT Number: NCT07382362

Preventing Neurologic Complications in Valve Surgery

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.

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Key information

Conditions

Left Atrial Appendage Closure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Left Atrial Appendage (LAA) Suture Closure

Procedure

Concomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon.

Surgical Valve Surgery

Procedure

Standard surgical valve repair or replacement performed according to routine clinical practice.

Primary outcomes

  1. Silent brain infarction (SBI)

    Time frame: Approximately postoperative day 5

    Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5.

Secondary outcomes

  1. Perioperative stroke

    Time frame: Within 30 days after surgery

    Incidence of clinically overt stroke within 30 days after surgery.

  2. Perioperative all-cause mortality

    Time frame: Within 30 days after surgery

    Death from any cause within 30 days after surgery.

  3. Perioperative MACCE

    Time frame: Within 30 days after surgery

    Incidence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of stroke, myocardial infarction, all-cause death, or cardiovascular death occurring within 30 days after surgery.

  4. Silent brain infarction (SBI) at 1 year

    Time frame: Occurrence of SBI assessed by brain MRI at 1 year after surgery.

    1 year after surgery

  5. MACCE at 1 year

    Time frame: Within 1 year after surgery

    Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) within 1 year after surgery, defined as a composite of stroke, myocardial infarction, all-cause death, cardiovascular death, or rehospitalization for heart failure.

Study contacts

Contact information is provided by the study sponsor or research team.

LIANXIN Chen

CONTACT

[email protected]

01088322265

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Strategies for the Prevention of Perioperative Neurological Complications in Cardiac Valve Surgery

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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