NCT07382362

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

January 25, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 25, 2026

Last Update Submit

January 25, 2026

Conditions

Left Atrial Appendage Closure

Outcome Measures

Primary Outcomes (1)

  • Silent brain infarction (SBI)

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

    Approximately postoperative day 5

Secondary Outcomes (5)

  • Perioperative stroke

    Within 30 days after surgery

  • Perioperative all-cause mortality

    Within 30 days after surgery

  • Perioperative MACCE

    Within 30 days after surgery

  • Silent brain infarction (SBI) at 1 year

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

  • MACCE at 1 year

    Within 1 year after surgery

Study Arms (2)

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

Valve surgery alone (no LAA procedure)

Standard surgical valve surgery without concomitant LAA suture closure.

Procedure: Surgical Valve Surgery

Interventions

Left Atrial Appendage (LAA) Suture ClosurePROCEDURE

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

Valve surgery with concomitant LAA suture closure
Surgical Valve SurgeryPROCEDURE

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

Valve surgery alone (no LAA procedure)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Peking University First Hospita

Beijing, Beijing Municipality, China

Location

Qingdao Cardiovascular Hospital

Qingdao, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, China

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Central Study Contacts

LIANXIN Chen

CONTACT

01088322265chenlianx1@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

January 27, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)