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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Left Atrial Appendage (LAA) Suture Closure

    Procedure/Surgery

    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/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Valve surgery with concomitant LAA suture closure1 intervention
Group B: Valve surgery alone (no LAA procedure)1 intervention

Trial outcomes

Primary outcomes

1

Silent brain infarction (SBI)

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

Time frame
Approximately postoperative day 5

Secondary outcomes

1

Perioperative stroke

Incidence of clinically overt stroke within 30 days after surgery.

Time frame
Within 30 days after surgery
2

Perioperative all-cause mortality

Death from any cause within 30 days after surgery.

Time frame
Within 30 days after surgery
3

Perioperative MACCE

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.

Time frame
Within 30 days after surgery
4

Silent brain infarction (SBI) at 1 year

1 year after surgery

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

Other outcomes

Sponsors and contacts

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