Preventing Neurologic Complications in Valve Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Left Atrial Appendage (LAA) Suture Closure, Surgical Valve Surgery.
- Who it may be relevant to
- Registry conditions: Left Atrial Appendage Closure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Strategies for the Prevention of Perioperative Neurological Complications in Cardiac Valve Surgery
Overview
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.
Interventions
- 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. - Procedure Surgical Valve Surgery
Standard surgical valve repair or replacement performed according to routine clinical practice.
Primary outcome measures
- Silent brain infarction (SBI) [Time frame: Approximately postoperative day 5]
Secondary outcome measures (5)
- Perioperative stroke [Time frame: Within 30 days after surgery]
- Perioperative all-cause mortality [Time frame: Within 30 days after surgery]
- Perioperative MACCE [Time frame: 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.]
- MACCE at 1 year [Time frame: Within 1 year after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 4 centers
- Fuwai Hospital Chinese Academy of Medical Sciences — Beijing
- Peking University First Hospita — Beijing
- Qingdao Cardiovascular Hospital — Qingdao
- Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen
Identifiers
NCT: NCT07382362 · 2024-2452