Preventing Neurologic Complications in Valve Surgery

January 25, 2026 updated by: China National Center for Cardiovascular Diseases

Strategies for the Prevention of Perioperative Neurological Complications in Cardiac 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Qingdao, China
        • Qingdao Cardiovascular Hospital
        • Contact:
      • Shenzhen, China
        • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Fuwai Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing Municipality, China
        • Peking University First Hospita
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

This is a multicenter observational study conducted at four participating hospitals in China. Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo elective open surgical heart valve surgery and provide informed consent will be enrolled. Participants will be grouped according to whether concomitant left atrial appendage (LAA) suture closure is performed during the index operation. The primary outcome is perioperative silent brain infarction (SBI) assessed by brain MRI at approximately postoperative day 5. Secondary outcomes include stroke, myocardial infarction, all-cause death, cardiovascular death, and MACCE within 30 days after surgery, as well as SBI and MACCE (including rehospitalization for heart failure) within 1 year after surgery.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Valve surgery with concomitant LAA suture closure
Concomitant suture closure of the LAA performed during surgical valve surgery.
Procedure: Left Atrial Appendage (LAA) Suture Closure
Concomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon.
Valve surgery alone (no LAA procedure)
Standard surgical valve surgery without concomitant LAA suture closure.
Procedure: Surgical Valve Surgery
Standard surgical valve repair or replacement performed according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately postoperative day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative stroke
Time Frame: Within 30 days after surgery
Incidence of clinically overt stroke within 30 days after surgery.
Within 30 days after surgery
Perioperative all-cause mortality
Time Frame: Within 30 days after surgery
Death from any cause within 30 days after surgery.
Within 30 days after surgery
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.
Within 30 days after surgery
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
Occurrence of SBI assessed by brain MRI at 1 year after surgery.
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.
Within 1 year after surgery

Collaborators and Investigators

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

Sponsor

China National Center for Cardiovascular Diseases

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 27, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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